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.
What you will do:- 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.
Who you are:- Bachelor's degree in Engineering or related Science field.
- 5+ years experience in quality engineering in a regulated environment
- Preferred experience in high volume manufacturing environments, using lean principals
- Preferred green belt and/or CQE
- Strong knowledge of either ISO 9001/13485/16949, FDA QSR, and risk management tools.
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
This job is also eligible for bonus/incentive pay.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
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