Sr. Quality Engineer
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Develop and maintain quality standards and protocols for processing materials into finished products. Collaborate with engineering and manufacturing teams to ensure quality systems, including change control and regulatory compliance, are operational. Design inspection mechanisms, conduct quality assurance tests, and perform statistical analysis to assess product reliability and nonconformance. Execute validation strategies for equipment qualification (IQ/OQ/PQ), process validation, and cleanroom activities in GMP environments. Evaluate regulatory impacts for facility modifications and equipment relocations to ensure adherence to FDA and ISO 13485 requirements.
Required Qualifications
- Bachelor's Degree in Mechanical, Biomedical, Industrial or Chemical Engineering
- five (5) years of exposure within the Medical Devices Industry
- Bilingual: Spanish and English
- Excellent teamwork skills
- Experience in Equipment & Process Validation
- Quality Systems & Change Control
- Regulatory Compliance & Manufacturing Change Management
- Expertise in developing, reviewing, approving and executing validation strategies and deliverables associated with equipment qualification (IQ/CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments
- Strong knowledge of Quality Management Systems (QMS), including change control, risk management, nonconformance investigations, and assessment of quality impact resulting from equipment, facility, and process changes
- Experience evaluating regulatory impact associated with facility modifications, equipment relocations, and process changes, ensuring compliance with FDA, ISO 13485, and applicable global regulatory requirements
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