Quality Assurance Lead
2 weeks ago
Overview: A prominent manufacturer in the medical device sector is seeking a Quality Assurance Manager with extensive experience in a GMP and FDA-regulated manufacturing environment. This organization is expanding its product offerings and integrating new machinery, which will require the Quality Manager to oversee validations for both new equipment and processes.
Responsibilities:
- Train team members on inspections, document management, and GMP compliance.
- Ensure adherence to FDA regulations while managing the Quality Laboratory.
- Utilize knowledge of CAPAs and root cause analysis to drive quality improvements.
- Monitor and ensure that KPI targets are consistently achieved.
Company Profile: This well-established corporation operates multiple facilities across the United States and presents an excellent opportunity for professionals looking to contribute to the launch of several innovative products aimed at increasing market share.
Qualifications: Candidates should possess a BS degree and a minimum of 3 years of experience in Quality Management. ASQ certifications are advantageous. Prior experience with FDA audits, regulatory agency interactions, and ISO certification processes is essential.
Additional Information: Relocation assistance is available for qualified candidates.
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