Quality Engineer, Medical Devices

Primary Talent Partners has a new contract opening for a Quality Engineer, Medical Devices with our healthcare client in San Diego, CA. This is a 24-month contract with a potential for extension.

Pay: $50.00 - $60.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


Description:
Quality Engineer supporting Post-Market Quality Engineering, ensuring compliance, CAPA support, risk documentation, cross-functional collaboration.


Responsibilities:

• Support Post-Market Quality Engineering activities to ensure ongoing compliance with FDA, ISO 13485, and internal quality system requirements.
• Lead and support investigations, root cause analyses, and corrective and preventive action (CAPA) activities for post-market quality issues and product performance concerns.
• Develop, maintain, and update risk management documentation, including risk assessments and product risk files, in accordance with applicable regulatory standards.
• Collaborate cross-functionally with Manufacturing, R&D, Regulatory Affairs, Supplier Quality, and Operations teams to drive quality improvements and resolve product quality issues.
• Analyze post-market data, customer complaints, nonconformances, and quality trends to identify opportunities for continuous improvement and risk mitigation.
  

Qualifications:

• Bachelor's in Engineering
• 4-10 years of Quality Engineering experience in a regulated industry, preferably medical devices, pharmaceuticals, or other FDA-regulated environments.
• Demonstrated experience with CAPA, root cause investigations, risk management methodologies (FMEA, risk assessments), and quality system requirements such as FDA 21 CFR Part 820 and ISO 13485.
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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