• Will be performing warehouse job duties such as counting, sorting, and recording of large, heavy-weight stock.
• Performs warehouse operations on the Receiving dock, picks orders, packs order and/or helps with dock processing.

• High School Diploma or equivalent.

• To stage, fill, cap, label, and over pack liquid, powder, and lyophilized products per approved packaging specifications and according to safety and quality protocols.
• Complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products to inventory.
• Fill, cap, and label chemical products
• Use electronic balances to properly weigh materials.
• Manually fill liquids or powders
• Set up and utilize semi-automated equipment to fill liquids or powders
• Perform routine cleaning to semi-automated equipment
• Perform fills in environmentally controlled areas
• Fill hazardous products
• Utilize pumps to transfer bulk solutions.
• Filter bulk materials using pumps and in-line filters or vacuum filters
• Manually torque caps with wrenches
• Set up and operate semi-automated cappers
• Hand label as necessary
• Set up and operate automated labelers
• Assist with loading bottles and pack-off during fill line operations
• Pack kits according to procedures.
• Use material handling equipment safely to transport materials throughout the

• Clean laboratory glassware and batch tanks.
• Follow all quality and safety procedures. Support quality systems
• Follow safety procedures at all times
• Don, doff, use, and clean PPE
• Follow Good Documentation Practices
• Document all equipment used and verify calibration status
• Be familiar with hazards common to assigned work and take action to correct unsafe

• Participate in required safety activities such as training sessions, meetings, and

• Develop and assist in the implementation of process improvement ideas
• Comply with the requirements of ISO 13485 and ISO 9001
• Participate in 6S activities
• Maintain good housekeeping and audit readiness

• Requires High School diploma or GED equivalent.
• At least 3 months chemical weighing, related laboratory, filling or packaging experience is preferred.
• Minimum of 3 months experience in ISO/GMP regulated environment is desirable.
• Basic math-including metrics and conversions
• Basic computer skills
• Knowledge of safety rules, GMP, SOP’s, UOP’s
• Hand-eye coordination
• Good written and oral communication skills
• Legible handwriting
• Strong mechanical aptitude
• Good interpersonal skills
• Ability to problem solve
• Ability to use hand tools
• Ability to occasionally lift 50 lbs.

• Perform production operation so Perform packaging operations per current production process and procedures.
• Transport chemicals and equipment to and from processes including use of pumps/piping, fork trucks, pallet jacks or dollies.
• Ensure quality and quantity of product throughout production process.
• Wear appropriate PPE for production processes which may include full face respirators, gloves, suit so Clean-up equipment and working areas after production operation so Coordinate appropriate disposal of waste and complete compliance documentation.
• Communicate and document status of processes, products, and equipment.
• Communicate the status of production operations/equipment and bring deviations to the attention of supervisor.
• Provide a complete and accurate batch record at the conclusion of production operations consistent with quality guidelines.
• Ensure all applicable log books have been filled out completely as required by current procedures
• Perform operations in compliance with rules and in a safe, orderly manner.
• Follow production procedures and safety policies at all time.
• Use, clean, and store all personal protective gear appropriately
• Label all in-process equipment and containers properly.
• Take the necessary action to resolve any unsafe conditions.
• Participate in required safety and quality training and other related activities.
• Maintain good housekeeping in laboratory and working areas

• Education/ AA in life science area with 1-2 years experience working in a similar environment or high school Diploma
• 1-3 years experience working in a similar environment
• Safe chemical handling methods
• Communication, oral and written
• Computer
• Mechanical
• Troubleshooting
• Interpersonal
• Organizational

• Performs work required for the assembly of components, devices and/or the final product with supervision
• Performs routine work in all production areas with limited supervision
• Ensures quality of product using standard operating procedures, templates, training and supervision, and good judgment
• Must perform all duties in a professional manner and work as a member of a team
• May be subject to call back or extended hours as required

• High school diploma or general education degree (GED), or equivalent combination of experience and education

• Performs raw material, in-process, and/or finished goods tests and reviews.
• Able to work in an environment with chemicals safely.
• Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.
• Monitors and reviews environmental charts and/or numeric data.
• Performs chemical and sterility release of product.
• Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.
• Carries out difficult calculations and prepares documentation that shows the results for the test performed.
• Prepares media and performs quality assurance control checks per USP.
• Investigate and write out-of-specification reports.
• Read and interpret results, perform trend analysis as required.
• Recommends, amends, and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
• Performs other duties assigned as by any member of Laboratory Management.
• Execute simple microbiology analyses in-process samples and finished products (Microbial count, Environmental Monitoring, and sterility test) to comply with current procedures and Pharmacopoeias.
• Basic knowledge of microbiology principles, theories, practices, and methodology.
• Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.
• Completes record of inspection results, acceptance, rejection, and disposition for entry into logbooks or computer systems (i.e. LIMS).
• Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)
• Responsible for ensuring adequate systematic control of nonconforming products.
• Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
• Experience in proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.
• Participates in special requests for product testing, such as qualification protocols
• Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems
• Conducts training for lower-level technicians and operations.
• Cross-trains to support other functional areas.
• Ensures proper safety and environmental procedures and practices are utilized
• Comply with all applicable quality management systems, and environmental, safety, and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

• University / Bachelor’s Degree or Equivalent is required with major on Science preferred.

• Good interpersonal relations and communication skills required
• Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended
• Demonstrated knowledge and expertise in quality processes and regulatory requirements.
• Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4)
• Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.
• Basic wet chemistry techniques related to qualitative and quantitative

• Performs raw material, in-process, and/or finished goods tests and reviews.
• Able to work in an environment with chemicals safely.
• Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.
• Monitors and reviews environmental charts and/or numeric data.
• Performs chemical and sterility release of product.
• Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.
• Carries out difficult calculations and prepares documentation that shows the results for the test performed.
• Prepares media and performs quality assurance control checks per USP.
• Investigate and write out-of-specification reports.
• Read and interpret results, perform trend analysis as required.
• Recommends, amends, and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
• Performs other duties assigned as by any member of Laboratory Management.
• Execute simple microbiology analyses in-process samples and finished products (Microbial count, Environmental Monitoring, and sterility test) to comply with current procedures and Pharmacopoeias.
• Basic knowledge of microbiology principles, theories, practices, and methodology.
• Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.
• Completes record of inspection results, acceptance, rejection, and disposition for entry into logbooks or computer systems (i.e. LIMS).
• Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)
• Responsible for ensuring adequate systematic control of nonconforming products.
• Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
• Experience in proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.
• Participates in special requests for product testing, such as qualification protocols
• Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems
• Conducts training for lower-level technicians and operations.
• Cross-trains to support other functional areas.
• Ensures proper safety and environmental procedures and practices are utilized
• Comply with all applicable quality management systems, and environmental, safety, and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

• University / Bachelor’s Degree or Equivalent is required with major on Science preferred.

• Good interpersonal relations and communication skills required
• Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended
• Demonstrated knowledge and expertise in quality processes and regulatory requirements.
• Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4)
• Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.
• Basic wet chemistry techniques related to qualitative and quantitative

• High School Diploma or equivalent
•  3+ years’ of related experience in a similar role
• Hands-on electro-mechanical repair, rebuild, field service experience
• Familiarity with formal preventative maintenance program 
• Knowledge of inventory control and asset management including spare part list development, preventative maintenance, and appropriate SOP’s pertaining to asset acquisition, validation, calibration and retirement
• Skill in using computer applications including spreadsheet, database, and word processing software.

• Technical Certificate as a Electro-Mechanical Technician, Industrial Maintenance Technician or a Technical Degree in Precision Machining and Manufacturing, Automotive Repair, or related technical field
• 3+ years’ experience as an electromechanical technician, experience with automation in the medical field
• 3+ years of diverse experience in high volume production setting
• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations

• Leads routine, periodic and special inspections to determine repairs needed or corrective actions taken to prevent breakdowns, unsafe conditions or to comply with Company and/or Agency Rules and Regulations
• Performs Production Equipment change-over as dictated by schedule or requested by shift supervisor (as needed or directed to best meet departmental objectives)
• Interprets blueprints, equipment manuals, layouts and wiring diagrams
• Leads the effort of preparing documentation regarding Preventive Maintenance and Machine Operation through effective communication and collaboration with Production Supervisors, Manager and Engineering
• Sets up and operates all equipment needed to perform assigned tasks
• Escorts and assists as necessary, outside repair persons in the performance of their contractual obligations
• Escorts Agency testing technicians to assure timely completion of their tasks as it relates to production equipment
• Maintains appropriate records, keeps inventory of spare parts and materials and provides Supervisor with the information necessary to secure needed replacement parts or special materials needed to effect proper repairs on all equipment
• Responds to alarm or trouble calls as required and maintains a strong floor presence. Functions as a key member of both the production & maintenance team and assists as necessary to accomplish production goals, and through-put initiatives

• Engineer therapeutics and perform biophysical, biochemical & biological analyses such as SPR/BLI for PPI assessment, enzymatic activity assays, cell culturing and transduction experiments
• Cell culture, flow cytometry and transduction efficiency experiments
• Operating FPLC for protein purification
• Independently design and execute well-controlled experiments
• Collect, analyze, interpret, and effectively communicate data
• Collaborate across research groups to support the development of therapeutics for both intracellular and extracellular targets
• Communicating with and presenting to collaborators across research community
• Perform other duties as required.

• BS, MS, or PhD in biochemistry, protein engineering, molecular biology, molecular virology or a related discipline, with significant wet-lab experience
• Excellent organizational communication and interpersonal skills required
• Knowledge of basic wet-lab skills including, but not limited to protein purification (FPLC) and characterization, PCR, construct design, cloning, biochemical and biophysical assays
• Proficiency with SPR / BLI, mammalian cell culture, flow cytometry, and/or working with adeno associated viruses (AAVs) is preferred
• Motivated, collaborative, self-directed, efficient
• Meticulous, detail-oriented and organized, with excellent problem solving and analytical skills.

• Performs raw material, in-process, and/or finished goods tests and reviews.
• Able to work in an environment with chemicals safely.
• Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.
• Monitors and reviews environmental charts and/or numeric data.
• Performs chemical and sterility release of product.
• Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.
• Carries out difficult calculations and prepares documentation that shows the results for the test performed.
• Prepares media and performs quality assurance control checks per USP.
• Investigate and write out-of-specification reports.
• Read and interpret results, perform trend analysis as required.
• Recommends, amends, and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
• Performs other duties assigned as by any member of Laboratory Management.
• Execute simple microbiology analyses in-process samples and finished products (Microbial count, Environmental Monitoring, and sterility test) to comply with current procedures and Pharmacopoeias.
• Basic knowledge of microbiology principles, theories, practices, and methodology.
• Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.
• Completes record of inspection results, acceptance, rejection, and disposition for entry into logbooks or computer systems (i.e. LIMS).
• Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)
• Responsible for ensuring adequate systematic control of nonconforming products.
• Recommends and implements revisions, corrections, and changes to test equipment, procedures, and methods.
• Experience in proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.
• Participates in special requests for product testing, such as qualification protocols
• Initiates and coordinates discussions with quality, engineering, and other relevant departments to develop corrective actions for reoccurring problems
• Conducts training for lower-level technicians and operations.
• Cross-trains to support other functional areas.
• Ensures proper safety and environmental procedures and practices are utilized
• Comply with all applicable quality management systems, and environmental, safety, and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

• University / Bachelor’s Degree or Equivalent is required with major on Science preferred.

• Good interpersonal relations and communication skills required
• Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended
• Demonstrated knowledge and expertise in quality processes and regulatory requirements.
• Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4)
• Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.
• Basic wet chemistry techniques related to qualitative and quantitative

• • Identification of the causes for non-conformances and engineering failures, and for the implementation of the remedial, corrective and preventive actions thus assuring engineering performance and compliance against Ethicon's QSR, GMP, and ISO requirements for the entire engineering processes.
  • Work with engineering personnel to ensure that effective in-depth investigations are performed in non-conformances, CAPAs and internal audit observations
  • Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
  • Complete non-conformance records accurately in ETQ in compliance to current procedures.
  • Monitors pending actions (NCAs, PDs, AP, etc.) for CAPA, NR and internal audits to ensure timely closure of CAPA, NR and internal audit observations
  • Writes or modifies procedures, protocols and any other Documentation needed for the enhancement of process/ equipment systems (e.g. network mix team actions).
  • Performs other duties assigned by supervisor/manager as needed.

"This is a non-exempt position. This position is responsible for the production of high quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed. Ensure that relevant job documentation for cell operations and functions is accurate and up to date. Be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form. Maintain a positive attitude when interacting with internal customers and external customers such as tours. Follow safety guidelines and utilize appropriate safety devices when performing all operations. Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics. Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products. Demonstrates a basis understanding of Lean Manufacturing. Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions - Understanding of and ability to utilize electronic data collection systems and computer software packages. Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance. Ability to handle and maneuver small components and parts. Ability to make critical decisions and judgments with minimal supervision. High school degree or equivalent required. Required dress code for tour during interview and on-the job: Clothing must be non-shedding and free of frayed hems or loose threads. Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodges are not allowed on clothing. To verify a fabric can be worn: pull at the fabric tightly with fingers, if fibers are dislodged, the garment may not be worn in the production area. Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn. All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.). All clothing, from the waist up, must fit under the lab coat/gown. Turtle necks or high-necked clothing shall not stick out above the neck of the lab coat/gown. Sleeves shall not stick out beyond the cuff of the lab coat/gown. Caps, hats, scarves or bandanas shall not be worn under the bouffant. Head wraps/scarves worn to accommodate customs: Must be covered with the bouffant and the tail end of the scarf must be fully covered by the lab coat/gown. Must be of tightly woven fabric, be clean, and laundered. Loose fitting clothing shall not be worn around machinery or soldering/brazing torches. Shoes must be worn at all times in the production area. Stockings or socks are required. The heel of a shoe must not be pointed or higher than 2 inches. Sandals, clogs, slippers, open toe, or open heel shoes are not allowed. Shoes with straps or weave where toes can be seen are not allowed. Changing shoes in the production area, other than a gowning room, is not allowed. Torsos, upper arms, and legs must be covered. Pants (above the ankle), skirts (above the ankle), skirts with slits, short shirts (above the navel), and sleeveless tops are not allowed. Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn under them. Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed. Jewelry or body piercings that can pierce gloves or cannot be covered under gowning materials will not be allowed in the production area. Makeup shall not be worn. Lip balm in stick form is acceptable, when applied outside of production areas and prior to hand washing. Scented personal use products shall not be worn, except deodorant. Lotions shall not be applied after hand washing. Cover any open or bleeding wound with a bandage. Don?t wear anything that could be offensive."

• • Locate and interview candidates for our clients. 
  • Timely review of applicants who have applied via the applicant tracking system. 
  • Source candidates via resume databases and networking sites using Boolean search language. 
  • Solicit and pursue referrals from business networks and/or internal referrals. 
  • Articulate value proposition for candidates who are interested in the job opportunity. 
  • Prepare candidates for interviews; providing logistical information, interview schedule, and expectations for follow up from the recruiter. 
  • Ensure all candidates are provided with timely updates concerning the status of their applications and interviews. 
  • Conduct professional and thoughtful phone interviews. 
  • Compare candidate phone interview notes and skills assessments with requisition specifications to determine if the candidate is a match for the role. 
  • Continuously build talent pipeline to ensure there are multiple candidates in play at all times. 
  • Articulate a job offer and drives for candidate acceptance. 
  • Provide accurate and regular reporting of recruiting activities. 
  • Proactively and regularly communicated the status of each search to the hiring manager. 

• Customer/Client Focus. 
• Human Resources Capacity. 
• Problem Solving. 
• Thoroughness. 
• Time Management. 
• Building relationships 

• High School Diploma/GED equivalency 
• Associates Degree 
• Two years of experience in recruiting or sales 

• Bachelor’s Degree in Marketing or Sales 
• One to two years of human resources experience; one to two years of human resources recruiting experience preferred 

• Must be able to effectively speak, write, and read in English and in regional languages, as applicable, for audits assigned.
• Thorough knowledge of QMS auditing principles and techniques.
• Prior experience managing and performing quality management system audits to applicable standards and regulations such as ISO 9001, ISO 13485, MDSAP, ISO 17025, and 21CFR’s 820, 11.
• Leadership skills to work and collaborate with all levels of management.
• Self-directed.
• Ability to build and maintain professional positive relationships with all groups.
• Proficient in using Microsoft office tools such as MS Word and Excel.
• Excellent written and verbal communication skills.
• Bachelor's degree (or regional equivalent) in a technical field or engineering.
•  3 – 5 years’ experience auditing medical device companies and/or associated supplier quality system lead auditor certification(s) preferred, e.g., ASQ CQA or CBA, ISO 9001/13485.

• Provides services from a self-registered business with an Employee Identification Number (EIN) if applicable.
• Provides proof of business insurance (for 1099’s).
• Submits invoices for services provided.

• Coordinates with suppliers to align on audit dates and conducts pre-audit planning including travel and accommodations where required. 
• Performs audits to applicable QMS standards and regulations at the supplier’s site or remotely as required by the customer. 
• Writes supplier audit reports to meet customer requirements.
• Updates audit tracking systems, e.g., EtQ for required audit updates.
• Reviews objective evidence of supplier corrective actions for acceptance.
• Attends and participates in audit related meetings as required by customers.

• Must be able to effectively speak, write, and read in English and German.
• Thorough knowledge of QMS auditing principles and techniques
• Prior experience managing and performing quality management system audits to applicable standards and regulations such as ISO 9001, ISO 13485, MDSAP, ISO 17025, and 21CFR’s 820, 11.
• Desirable: Ability to speak, write and read in additional European languages.
• Leadership skills to work and collaborate with all levels of management
• Ability to be self-directed and work under minimal supervision
• Ability to build and maintain professional positive relationships with all groups
• Must have a “Can do” attitude
• Must strive and be committed to “get the job done” and meet all deadlines
• Proficient in using Microsoft office tools such as MS Word and Excel
• Ability to handle multiple and complex tasks.
• Excellent written and verbal communication skills

• Bachelor's degree in a technical field or engineering. 
• 3 – 5 years’ experience auditing medical device companies and/or associated suppliers
• Quality system auditor qualifications preferred, e.g., ASQ CQA or CBA, ISO 9001/13485 certified lead auditor.