Senior Quality Engineer - Life Sciences & Med Devices

Cytiva; Pensacola (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

Cytiva in Pensacola, FL is seeking a Senior Quality Engineer to lead quality initiatives for membrane products and medical devices, ensuring QMS compliance and driving continuous improvement. This on-site role reports to the Site Quality Senior Manager and supports new product introductions.

The incumbent will collaborate with R&D, manufacturing, and regulatory teams to maintain product safety and regulatory compliance while applying ISO 9001/13485 standards and risk management tools.

Qualifications

• 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 principles.
• Preferred green belt and/or CQE.
• Strong knowledge of ISO 9001/13485/16949, FDA QSR, and risk management tools.

Responsibilities

• Provide strategic quality oversight for manufacturing operations, ensuring regulatory standards compliance across production teams.
• Led complex root cause investigations using 8D, DMAIC, and fishbone analysis with robust corrective and preventive actions.
• Directed process validation and control strategies (IQ/OQ/PQ, SPC) to improve process capability and reduce variability.
• Applied risk-based PFMEA and ISO 14971 principles to identify and mitigate process risks.
• Collaborated with engineering, operations, and suppliers to drive continuous improvement and support product transfers and launches.

Skills

Quality engineering

Root cause analysis

DMAIC

8D

Risk management

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in Engineering or related Science field

Tools

IQ/OQ/PQ

SPC

PFMEA

Job description

Cytiva in Pensacola, FL is seeking a Senior Quality Engineer to lead quality initiatives for membrane products and medical devices, ensuring QMS compliance and driving continuous improvement. This on-site role reports to the Site Quality Senior Manager and supports new product introductions.

The incumbent will collaborate with R&D, manufacturing, and regulatory teams to maintain product safety and regulatory compliance while applying ISO 9001/13485 standards and risk management tools.