Senior Quality Lead: Lab & Metrology
RXinsider LTD.
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Benefits offered by this job
Job summary
West is seeking a Senior Quality Specialist (Laboratory) in Indiana to provide quality systems oversight and customer‑facing quality support for WSS, Metrology, and Laboratory operations. The role drives QMS maintenance, timely closure of issues, and compliance with regulatory and customer requirements across GMP/ISO standards.
The ideal candidate will lead investigations, CAPA programs, risk management, and data‑driven improvements while collaborating with cross‑functional teams to ensure
Qualifications
- 5+ years in Quality Assurance roles.
- Experience with CAPA, deviations, change control, document control.
- Knowledge of ISO 13485, 21 CFR Part 820, GMP.
- Strong communication and cross‑functional collaboration.
- Lead investigations with root‑cause analysis and corrective/preventive actions.
Responsibilities
- Establish and maintain QMS for WSS, Metrology, and Laboratory ops.
- Provide QA oversight for CAPA, deviations, change control, investigations, calibration, and audits.
- Support regulatory responses, customer requests, and inspection readiness.
- Plan and support internal/external audits and responses.
- Review and approve quality documentation and records across the operation.
Skills
Education
Tools
Job description
West is seeking a Senior Quality Specialist (Laboratory) in Indiana to provide quality systems oversight and customer‑facing quality support for WSS, Metrology, and Laboratory operations. The role drives QMS maintenance, timely closure of issues, and compliance with regulatory and customer requirements across GMP/ISO standards.
The ideal candidate will lead investigations, CAPA programs, risk management, and data‑driven improvements while collaborating with cross‑functional teams to ensure
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