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Quality engineer

Talent GroupsUnited States🇺🇸United States

Why this role stands out

This hybrid Quality Engineer role at Talent Groups offers a fantastic opportunity to drive significant improvements in medical device manufacturing, developing your expertise in global regulatory standards and process validation. You'll thrive here if you are a seasoned engineer with a passion for quality, risk management, and continuous improvement in a regulated environment. Apply now to leverage your skills and contribute to impactful projects with a reputable company.

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationUnited States

Job description

Job Summary:
Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.
Key Responsibilities:
•Lead manufacturing quality assessments and process audits.
•Drive FPY improvement and defect reduction initiatives.
•Review process validation (IQ/OQ/PQ) and risk management activities.
•Manage CAPA, nonconformance, and supplier quality issues.
•
Support FDA, ISO 13485, MDSAP, and regulatory audits
Required Skills:
• Manufacturing Quality Engineering.
• Process Validation and TMV.
• SPC, MSA, and PFMEA.
• CAPA and Nonconformance Management.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971
Preferred Qualifications:
•Bachelor's/Master's degree in Engineering discipline.
•8+ years of Medical Device Manufacturing Quality experience.
•Experience with Class II/III medical devices.
•Experience supporting regulatory audits and inspections

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