Manufacturing Engineer â Medical Devices (IQ/OQ/PQ Focus)
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Job Location:
Gainesville, FL - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Title: Manufacturing Engineer Medical Devices (IQ/OQ/PQ Focus)
Location: Gainesville FL (On-site)
Duration: Long Term Contract
Position Summary:
Our client is seeking a highly skilled Manufacturing Engineer with a strong background in the medical device industry and extensive experience in IQ/OQ/PQ validation activities. The successful candidate will ensure that manufacturing processes meet regulatory requirements improve efficiency and maintain the highest quality standards.
Key Responsibilities:
- Lead and execute Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) for new and existing equipment and processes.
- Develop and maintain process validation protocols reports and associated documentation in compliance with ISO 13485 FDA 21 CFR Part 11 and GMP requirements.
- Collaborate with Quality R&D and Production teams to ensure smooth transfer of new products into manufacturing.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for process deviations.
- Optimize manufacturing processes to improve yield reduce cost and maintain compliance.
- Support equipment selection procurement and installation.
- Ensure adherence to environmental health and safety (EHS) guidelines.
Qualifications:
- Bachelors degree in Mechanical Manufacturing Industrial Engineering or related field.
- Experience: 6-8 years
- 6 years of experience in manufacturing engineering within the medical device industry.
- Proven experience with IQ/OQ/PQ execution and documentation.
- Strong understanding of validation requirements under FDA and ISO regulations.
- Excellent problem-solving and documentation skills.
Key Skills
- Lean Manufacturing
- Six Sigma
- CNC Programming
- Lean
- Machining
- Tooling
- CAD
- CNC
- Assembly Experience
- SolidWorks
- Kaizen
- Manufacturing
