Medical Device Quality Assurance Engineer

Summary: Seeking a Medical Device Quality Assurance Engineer to support nonconformance investigations, supplier issues, and product development activities.

• Requirements:

  • 3-5 years of manufacturing quality experience in the medical device industry
  • Extensive knowledge of 21 CFR 820 and ISO 13485
  • Strong proficiency in Microsoft Word and Excel
  • Experience with electro-mechanical assembly, ESD controls, cabling, clean room processes, labeling, sterilization

• Preferred Skills:

  • Knowledge of advanced statistical methods and software tools like Minitab
  • Experience in process validation and test method validation/Gage R&R activities
  • Prior start-up experience

• Responsibilities:

  • Support material nonconformance investigation and disposition activity
  • Assist with maintenance of calibration system
  • Support creation and maintenance of DHRs, routers, bills of material for manufacturing
  • Perform incoming inspection review for product components
  • Document activities in compliance with medical standards and regulations
  • Assist in quality issue investigations from product complaints, CAPAs, non-conforming reports

Pay Details: $95,000.00 to $110,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance