Senior Quality Engineer – Life Sciences QA & QMS

Radiometer; Pensacola (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Cytiva, a Danaher operating company, is seeking a Senior Quality Engineer in Pensacola to ensure membrane products and medical devices meet ISO 13485 and ISO 9001 standards, and to drive quality across production.

The role leads cross‑functional quality oversight, conducts root cause investigations, and implements CAPA using 8D/DMAIC, PFMEA, and IQ/OQ/PQ in high‑volume manufacturing, while supporting new product introductions.

Qualifications

• Bachelor’s degree in Engineering or related Science field.
• 5+ years in quality engineering in a regulated environment.
• Experience in high-volume manufacturing and lean principles preferred.
• Green belt and/or CQE preferred.
• Strong knowledge of ISO 9001/13485/16949, FDA QSR and risk management tools.

Responsibilities

• Provided strategic quality oversight for manufacturing operations, ensuring regulatory compliance 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.

Skills

Quality engineering

Regulated environment

Lean principles

CQE/Green belt

Regulatory standards knowledge

Education

Bachelor’s degree in Engineering or related Science

Job description

Cytiva, a Danaher operating company, is seeking a Senior Quality Engineer in Pensacola to ensure membrane products and medical devices meet ISO 13485 and ISO 9001 standards, and to drive quality across production.

The role leads cross‑functional quality oversight, conducts root cause investigations, and implements CAPA using 8D/DMAIC, PFMEA, and IQ/OQ/PQ in high‑volume manufacturing, while supporting new product introductions.