
Chief Manufacturing Process Developer
5 days ago
Job Overview:
">We are seeking a skilled Manufacturing Engineer to partner closely with our manufacturing and quality teams to strengthen compliance and support process validation projects.
About the Role:
">- Work alongside manufacturing owners to identify gaps and implement corrective actions to achieve compliance.
- Contribute to equipment and process validation activities (IQ/OQ/PQ).
- Revise and maintain quality system records and technical documentation to ensure audit readiness.
- Lead and support the closure of CAPAs and NCRs with robust corrective actions.
- Develop clear, accurate technical documentation and SOPs for quality and manufacturing processes.
Requirements:
">- Degree in Engineering, Quality, or a related discipline.
- 2–5 years of experience in medical device manufacturing, quality engineering, or remediation work.
- Strong background in process validation (IQ/OQ/PQ) and CAPA/NCR resolution.
- Excellent technical writing and documentation abilities.
- Solid understanding of 21 CFR Part 820 and ISO 13485 requirements.
- Strong problem-solving mindset, with the ability to drive issues to fully compliant solutions.
What We Offer:
">A challenging opportunity to develop your skills and expertise in a collaborative environment.
Key Skills and Qualifications:
">Manufacturing Engineer
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