Medical Device Quality Engineer – QMS & Compliance

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

Benefits offered by this job

PTO

401k match

Health Savings Account

Stock purchase plan

Education reimbursement

Job summary

Philips invites applications for a Service Quality Engineer in Gainesville, FL. The role focuses on bridging quality management systems with service delivery to meet customer needs and regulatory requirements.

You will support QMS activities across departments, drive CAPA initiatives, and participate in audits to ensure compliance with ISO 13485, MDSAP, and CFR. Office-based with onsite presence is required.

Qualifications

• 2+ years of experience in Quality Engineering or related fields.
• Experience in medical device or regulated industries preferred.
• Ability to support QMS across departments and sites.
• Office-based role with onsite presence required.

Responsibilities

• Support Quality Management System (QMS) activities across departments, sites, and businesses.
• Lead or participate in process improvement initiatives, often under regulatory scope.
• Assist audits and ensure compliance with ISO 13485, MDSAP, MDD, EU-MDR, and CFR.
• Manage CAPA to address defects, non-conformances, and quality events.
• Apply risk assessment tools to service and delivery processes.
• For software-involved devices, assess design tests and root causes.

Skills

Quality Engineering

Process Engineering

Regulatory knowledge

Risk assessment

Education

Bachelor's degree in engineering or science

Master's degree preferred

Tools

PFMEA

CAPA

Job description

Philips invites applications for a Service Quality Engineer in Gainesville, FL. The role focuses on bridging quality management systems with service delivery to meet customer needs and regulatory requirements.

You will support QMS activities across departments, drive CAPA initiatives, and participate in audits to ensure compliance with ISO 13485, MDSAP, and CFR. Office-based with onsite presence is required.