Job Description
About the Role
Join a growing medical device company focused on innovation and patient impact. We’re looking for a Quality Manager to lead and strengthen quality systems, ensure compliance, and drive continuous improvement across manufacturing operations.
What You’ll Do
- Manage and maintain the Quality Management System (QMS)
- Lead CAPA, root cause investigations, and quality improvements
- Oversee audits, compliance, and regulatory readiness (FDA & ISO)
- Drive KPI tracking, reporting, and process optimization
- Support product quality, non-conformance handling, and documentation control
What We’re Looking For
- Experience in GMP-regulated industries (Medical Device / Pharma / Manufacturing)
- Strong knowledge of FDA regulations & ISO standards (13485 / 9001)
- Hands-on experience with CAPA, audits, and investigations
- Familiarity with quality tools (FMEA, 8D, Lean, SPC, etc.)
- Strong leadership, communication, and problem-solving skills
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.