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Quality Assurance Manager
7 days ago
Medical Device Manufacturing
(Please note: our client will only consider candidates already local to the Indianapolis IN area; no relocation)
Join team as a Quality Assurance Manager and play a crucial role in supporting our daily operations to ensure regulatory compliance, uphold quality practices, and drive continued growth. In this position, you will oversee activities related to cGMP manufacturing, packaging, testing, and storage, and you will participate in relevant audits. Collaboration is key, as you will work cross-functionally with Operations, Engineering, Distribution, R&D, Marketing, Sales, and other team members to maintain an organized, efficient, and FDA-compliant quality management system (QMS). Additionally, you will ensure that QA/QC processes adhere to all applicable regulations and business policies. Responsibilities also include managing department staff reviews and setting annual performance goals. More details available upon request.
Requirements:
- 8+ years of experience in Quality Assurance, preferably within the medical device industry or a related field
- Bachelor's degree in Sciences, Engineering, or a technical discipline
- Direct experience in manufacturing
- Proven ability to coach and mentor team members
- Strong knowledge of quality systems and regulatory compliance in medical devices, including FDA and ISO standards
- Experience with QMS and ISO (implementation experience is a plus)
Preferred Certifications:
- Certified Quality Auditor (CQA)
- Certified Quality Engineer (CQE)
- Certified Quality Manager (CQM)
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