Quality Engineer

Quality Engineer | Medical Device Manufacturing

I'm partnering with an established manufacturer in the healthcare industry seeking an experienced Quality Engineer to join their team.

This role will play a critical part in supporting product quality, validation activities, investigations, corrective actions, and continuous improvement initiatives within a regulated manufacturing environment. The ideal candidate is analytical, detail-oriented, and passionate about driving quality excellence.

What You'll Be Doing:

• Lead quality investigations, non-conformance assessments, CAPAs, and corrective actions
• Support validation activities and quality system initiatives
• Partner with operations teams to improve manufacturing processes and product quality
• Conduct root cause analysis and implement sustainable solutions
• Support internal and external audits
• Utilize statistical tools and engineering principles to drive continuous improvement
• Ensure compliance with FDA regulations, GMP requirements, and ISO standards

What We're Looking For:

• Bachelor's degree in Engineering (Quality, Industrial, Mechanical, or related field)
• 5+ years of Quality Engineering or Quality Assurance experience
• Knowledge of FDA regulations and medical device quality systems
• Experience with CAPA, SCARs, non-conformances, complaints, and root cause investigations
• Familiarity with ISO 13485, ISO 14971, and device quality requirements
• Strong analytical, project management, communication, and technical writing skills

Work Schedule: Onsite

Compensation: $80-90k base

Benefits: Medical, dental, vision, paid sick leave where applicable by state law

Equal Opportunity Employer/Veterans/Disabled

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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