Manufacturing Engineer â Medical Devices (IQ/OQ/PQ Focus)
Manufacturing Engineer â Medical Devices (IQ/OQ/PQ Focus)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Employment Type
Full-time
