Quality Auditor
Burlington, MA
Experience: 0
Category: Engineering
Brand: Joule
Job ID: 292873
Date Posted: 12/29/2022
Shortcut: http://jobs.systemoneservices.com/1ZwcO5
Title: Quality Engineer-Internal Audit
Location: Burlington, MA area
Start Date: ASAP!!
Duration: Direct Hire
Hours: Mon-Fri; 8am-4:30pm
Primary Duties/Responsibilities:
- Executes day to day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
- Evaluates medical device failures (product complaints) and writes a summary report
- Determines root cause and implements Corrective and Preventative Actions
- Reads and Interpret Standards in biocompatibility, sterilization and mechanical product testing for developing and updating Standard Operating Procedures and Reviewing or Creating Protocols/Reports.
- Evaluates risk in product design and the manufacturing process of medical devices
- Audits the manufacturing process to confirm compliance to procedures used to manufacture medical devices for assembly, packaging, chemistry formulation of solutions, inspections and testing of the medical devices.
- Updates the quality system based on non-conformities found during internal and external audits
- Reviews Non-Conforming Material Reports for plan and disposition
- Analyzes and reports quality system data to the quality and manufacturing team
- Evaluates supplier performance based on data collected at incoming inspections.
Requirements:
- BS degree in chemistry, physics, chemical engineering, biomedical or mechanical engineering
- 2-5+ yrs. experience in the Med Device or Pharma industry in a similar role
- Mechanical aptitude and/or biologic mindset(Microbiology or chemistry background)
- Experience with Quality Systems
- Experience with CAPA
- Experience with Compliance
- Experience with Non-Conformities
- Design control experience is a plus
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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