Medical Device Quality Assurance Engineer

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

Job summary

Philips is seeking a Service Quality Engineer to bridge QMS and service delivery, ensuring customer needs and regulatory standards are met while driving CAPA and risk management across departments. Office/remote flexibility with a strong emphasis on onsite collaboration.

Ideal candidates will have a mechanical/electronics or science background and 2+ years in quality or process engineering, with a preference for 3+ years in medical devices.

Qualifications

• Bachelor's or Master's degree in Mechanical or Electronics Engineering, Science or equivalent.
• 2+ years of experience in Quality Engineering, Safety Engineering or Process Engineering with a Bachelor's degree.
• Preference for 3+ years in medical device or process engineering.

Responsibilities

• Quality Management System (QMS) Support: Facilitate and manage QMS activities across departments, sites, and businesses.
• Process Improvement: Lead or participate in initiatives to improve service and delivery processes, often under a regulatory scope.
• Audits & Compliance: Support internal and external audits, ensuring adherence to standards such as ISO 13485, MDSAP, MDD, EU-MDR, and CFR.
• Corrective & Preventive Actions (CAPA): Initiate and manage CAPA to address defects, non-conformances, and quality notifications.
• Risk Management: Apply risk assessment tools and principles to service and delivery processes.
• Software Quality: For roles involving software as a medical device, assess design, review tests, analyze market feedback, and perform root cause analysis.

Skills

QMS knowledge

Quality Engineering

Process Improvement

Audits & Compliance

CAPA

Risk Management

Software Quality

Education

Bachelor's/Masters Degree in Mechanical or Electronics Engineering or Science

Job description

Philips is seeking a Service Quality Engineer to bridge QMS and service delivery, ensuring customer needs and regulatory standards are met while driving CAPA and risk management across departments. Office/remote flexibility with a strong emphasis on onsite collaboration.

Ideal candidates will have a mechanical/electronics or science background and 2+ years in quality or process engineering, with a preference for 3+ years in medical devices.