Manufacturing Quality Assurance Manager
Listed on 2026-11-01
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Role:
Manufacturing Quality Assurance (MQA) Manager overseeing quality activities at the Cedar Creek site, ensuring compliance with regulatory standards and internal policies. Responsibilities include leading and developing a QA team, maintaining inspection readiness, supporting audits, overseeing quality systems (deviations, investigations, CAPA, change controls), and providing quality oversight for manufacturing operations. The role emphasises continuous improvement, validation oversight, and effective communication of quality metrics.
- Bachelor's degree in Science, Engineering, or related field
- 8+ years of regulated manufacturing quality experience (medical device, pharma, biotech)
- 3+ years in leadership roles
- strong knowledge of FDA, ISO 13485, cGMP, and QMS
- Preferred skills encompass leadership, problem-solving, risk assessment, and data analysis capabilities; experience in medical device manufacturing and supporting regulatory audits preferred.
High-Value: regulated biotech/pharma manufacturing, quality systems, compliance with FDA/ISO, quality metrics, continuous improvement initiatives.
Work setup: full-time, day shift, occasional travel, remote or onsite.
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