• Develop, document, and implement QA procedures
• Interpret and assess conformity to regulatory standards
• Provide analytical investigations and develop root cause for non-conformances
• Design and specify gauging and test equipment for quality assurance
• Write protocols, analyze data, and generate summary reports for verifications and validations
• Lead and participate in design control projects for new and changing medical devices
• Interface with vendors and customers as required
• Participate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.
• Conduct supplier evaluations, qualifications, and quality audits
• Reviewing all lab results and approve product release.
• Working in a team environment with Quality Department and J- Pac Medical personnel.
• Supplier Quality Tracking (assist in Supplier Quality Audits as required)
• backup for inspection and test (incoming, in-process & final)
• Assisting/Participating in Customer Audits (as needed)

• BS or MS in Engineering, or scientific disciple with 5-7 years of experience in the manufacture of medical devices/disposables (Class II) for the medical device market
• 3 years Medical Device industry experience preferred
• Certified Quality Engineer or Quality Auditor (ASQ) preferred
• Experience with design control, process validation, failure investigations, root cause analysis, and the application of statistics to the practice of quality assurance
• Experience participating in FMEAs or other risk assessment activities
• Experience with supporting FDA and certified body audits
• Clean room experience
• Team player with strong communication, interpersonal, and presentation skills
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings, and procedure manuals
• Strong computer, math, writing, and problem-solving skills
• Expert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices; knowledge of ISO 14971 and device-related compliance standards
• Knowledge of lean manufacturing principles

Leveraging the power of relationship building and the Adecco brand, we work to align candidates with permanent positions based on skillset and job requirements. Our personal and tailored approach assures that our candidates are placed into positions that align with their long-term goals. We specialize in recruiting for permanent positions within the Life Sciences industry. Here are just some of the roles we specialize in: - Biotechnology - Pharmaceutical - Clinical Research/Trials - Medical Devices - Quality Assurance - Engineering