Quality Assurance Engineer – Medical Devices & QMS

Philips; Gainesville (FL); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

PTO (paid time off)

401k with match

HSA with company contribution

Stock purchase plan

Job summary

Philips is seeking a Service Quality Engineer in Gainesville, FL, to bridge quality management systems with service delivery and ensure regulatory and internal standards are met.

The role involves supporting QMS activities, driving process improvements, and participating in audits, CAPA, and risk management for medical-device related services. Office-based, onsite with a strong emphasis on compliance and quality processes.

Qualifications

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Responsibilities

• Support QMS activities across departments and sites
• Lead or participate in process-improvement initiatives
• Support audits and ensure compliance with ISO 13485, MDSAP, MDD, EU-MDR, CFR
• Initiate and manage CAPA to address defects and non-conformances
• Apply risk assessment to service processes
• Assess PFMEA impact with design changes and assist in service design transfer

Skills

Quality engineering

Process engineering

Safety engineering

2+ years experience

Education

Bachelor's/Master's in Engineering or Science

Job description

Philips is seeking a Service Quality Engineer in Gainesville, FL, to bridge quality management systems with service delivery and ensure regulatory and internal standards are met.

The role involves supporting QMS activities, driving process improvements, and participating in audits, CAPA, and risk management for medical-device related services. Office-based, onsite with a strong emphasis on compliance and quality processes.