
Senior Manufacturing Quality Engineer
2 weeks ago
Quality Assurance Professional
">This is a senior quality assurance role within the medical device industry. The ideal candidate will have experience in manufacturing, supplier oversight, and regulatory compliance.
">Responsibilities
">- Oversee quality for electronics/system-level manufacturing with contract manufacturers.">
- Lead investigations and corrective actions for non-conformances.">
- Support validation and documentation reviews.">
- Monitor supplier quality and contribute to audit preparedness.">
- Collaborate on regulatory submissions and inspection readiness.">
Requirements
">- Degree in Engineering, Quality, or a related discipline.">
- 3-7 years of experience in quality assurance or manufacturing quality within a regulated industry.">
- Strong knowledge of ISO 13485, FDA QSR, and process validation.">
- Experience supporting regulatory audits or working with Regulatory Affairs teams.">
- Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications.">
About this Opportunity
">A reputable company is seeking a skilled professional to support commercial manufacturing of a connected health solution for chronic wound care.
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