Senior Quality Engineer
About The Position
The Senior Quality Engineer is responsible for ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, implementing quality control measures, and identifying statistical trends. This role ensures compliance with ISO 13485, and ISO 9001 standards, addresses customer complaints, resolves production quality issues, and supports new product introduction projects. Additionally, the Senior Quality Engineer drives continuous improvement, and collaborates with R&D, manufacturing, and regulatory teams to maintain product safety and regulatory compliance. This position reports to the Senior Manager, Site Quality and is part of the Quality Engineering group located in Pensacola and will be an on-site role. This role is for working days of Sunday to Thursday.
Requirements
- Bachelor’s degree in Engineering or related Science field.
- 5+ years experience in quality engineering in a regulated environment
- Strong knowledge of either ISO 9001/13485/16949, FDA QSR, and risk management tools.
Nice To Haves
- Preferred experience in high volume manufacturing environments, using lean principals
- Preferred green belt and/or CQE
Responsibilities
- Provided strategic quality oversight for manufacturing operations, ensuring compliance with applicable regulatory standards while driving a culture of quality excellence across production teams.
- Led complex root cause investigations and remediation efforts using tools such as 8D, DMAIC, and fishbone analysis, implementing robust corrective and preventive actions to eliminate recurring issues.
- Directed process validation and control strategies (IQ/OQ/PQ, SPC), improving process capability, reducing variability, and maintaining consistent product quality in high-volume manufacturing environments.
- Applied risk-based approaches (PFMEA, control plans, ISO 14971 principles) to proactively identify and mitigate process risks, ensuring product safety, reliability, and compliance.
- Collaborated cross-functionally with engineering, operations, and suppliers to drive continuous improvement initiatives, optimize manufacturing processes, and support successful product transfers and launches.
Benefits
- health care program
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
