Senior Sustaining Quality Engineer

Are you passionate about driving quality and compliance in cutting-edge medical technology? Our tenured Class II Medical Device client is seeking a Senior Sustaining Quality Engineer to join their dynamic team. In this role, you will lead initiatives to maintain and improve the quality, reliability, and compliance of innovative medical devices currently in production.

• Resolve manufacturing issues through root cause analysis and corrective actions (NCMRs, CAPA, SCAR).
• Manage supplier change notifications and ensure compliance with 21 CFR Part 820 and ISO 13485.
• Support yield and cost improvement projects for on-market products.
• Lead Final QC functions and supplier audits.
• Drive risk management activities (Hazard Analysis, FMEA) and process validations (IQ/OQ/PQ).
• Collaborate cross-functionally to support complaint investigations and product transfers.

• 5+ years of Medical Device experience in Quality
• Experience working in smaller start-up environments
• Experience with process validation and process improvement
  • IQ,OQ,PQ, TMV etc..
• Experience owning and leading risk management, pFEMA projects
• Background in working with manufacturing/production line
  • Internal OEM, or CMO experience

Apply NOW for Immediate Consideration!

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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