Senior Quality Engineer (Med Device

Senior Quality Engineer (Med Device) – CAPA / Continuous Improvement

Company : Randstad (Recruiting for a Leading Global Medical Device Client)

Location : North Austin, TX (On-site)

Job Type : Contract (7 Months) with Extension Possibility

Pay Rate : Up to $48.00 / hr

The Opportunity

Our client, a leader in the global medical device industry, is urgently seeking a highly experienced and process-focused Senior Quality Engineer (QE) to join their North Austin site. This is a critical, hands-on role where you will act as the Subject Matter Expert (SME) for the Quality Management System (QMS), specifically driving continuous improvement, leading complex investigations, and ensuring ongoing compliance for orthopedic devices. We need an expert QE who can hit the ground running to support operational and inspection processes as the site approaches closure milestones.

Key Responsibilities & Impact

• CAPA & Non-Conforming Investigations (20%) : Serve as the SME, leading / participating in CAPA and non-conforming investigations to determine appropriate corrective actions and coach other engineers.
• Continuous Improvement & Quality Programs (40%) : Lead continuous improvement efforts to eliminate / reduce future recalls and develop quality programs to ensure product specifications and regulatory standards are met.
• Cross-Functional Project Support (20%) : Work with Operations, Regulatory, and Product Development teams to ensure projects meet QMS requirements and support the successful launch of new products.
• Audits & Risk Management (15%) : Prepare strategy for and represent the site during internal and external audits. Lead data analysis for risk-related activities (MSA, FMEA, GRR).

Qualifications & Essential Skills

Top 3 Skills (Immediate Need)

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