JOB DESCRIPTION
Summary/Objective
The Supplier Quality Auditor is located in North America & conducts supplier quality system audits, both on site and remote audits to applicable quality management system standards for Fortune 500 companies. The auditor conducts audits of suppliers across different industries such as Medical device, Pharmaceutical, Consumer, Biotechnology, Microbiology and Sterilization Sciences as needed to meet customer requirements. The auditor must have the written and oral language skills to conduct supplier audits in English and other country specific languages in North America for assigned audits.
Responsibilities
· 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 and issues supplier audit reports to meet customer requirements.
· Updates audit tracking systems for audit status updates.
· Issues audit reports per customer requirements.
· Attends and participates in audit related meetings as required by customers.
Other Duties
Other duties may be assigned as required by BEPC management.
Competencies
· Must be able to effectively speak, write, and read in English.
· 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
· 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 SharePoint, Word and Excel
· Ability to handle multiple and complex tasks.
· Excellent written and verbal communication skills
· Primary duty includes the exercise of discretion and independent judgment with respect to matters of significance.
Supervisory Responsibility
This position is an individual contributor position.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers and smartphones.
Position Type/Expected Hours of Work
This is a full-time position, and hours of work typically Monday through Friday, 8:00 a.m. to 5:00 p.m. However, agility and quick response time to customer and employee requests may be required at other times to include evening and weekends.
This is a remote position. The candidate must be located in North America.
Travel
Able to travel approximately 60% of time performing audits as required to meet customer & business needs.
Required Education and Experience
· 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, CMDA or CBA, ISO 9001/13485 certified lead auditor.
· Analytical laboratory experience and/or experience auditing laboratories is desirable.
AAP/EEO Statement
BEPC Inc. policy is to affirmatively implement equal opportunity for all employees and applicants for employment without regard to race, color, religion, sex, national origin, disability, military status, genetic information, or any other basis prohibited by law. Additionally, BEPC Inc. does not discriminate against an employee or applicant who acts to oppose such discrimination or participates in the investigation of a complaint related to discriminatory employment practice. Employment decisions will be made on the basis of each applicant’s job qualifications, experience, and abilities.