Quality Engineer – Medical Devices

Job Title:

Quality Engineer – Medical Devices

Location:

Austin, Texas

Employment Type:

Contract (W2 Only)

Job Summary:

We are seeking a detail-oriented Quality Engineer to ensure compliance and continuous improvement within medical device manufacturing operations. This role supports quality systems, regulatory compliance, and product lifecycle activities in accordance with FDA, ISO, and GMP standards.

Key Responsibilities:

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards
• Lead and support CAPA investigations, root cause analysis (5 Why, Fishbone), and corrective actions
• Manage Non-Conformance Reports (NCR) and Material Review Board (MRB) activities
• Support complaint handling, adverse event reporting, and post-market surveillance
• Participate in risk management and Design Control activities (FMEA, DHF, DMR, DHR)
• Develop, review, and approve validation protocols and reports (IQ/OQ/PQ, process validation, cleaning validation)
• Conduct internal audits and supplier audits; support external audits and regulatory inspections
• Review and approve SOPs, work instructions, and quality documentation
• Perform statistical analysis and apply quality tools (SPC, Control Charts, Pareto Analysis)
• Support change control processes and continuous improvement initiatives
• Collaborate cross-functionally with Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3–6+ years of experience in medical device quality engineering
• Strong knowledge of GMP, QMS, risk management, and validation requirements
• Experience with audit management and regulatory inspections preferred
• CQE or ASQ certification is a plus

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