Onsite Senior Quality & CAPA Engineer

Philips; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

Generous PTO

401k match

HSA contributions

Stock purchase plan

Education reimbursement

Total Rewards benefits

Job summary

Philips is seeking a Senior Quality Operations Engineer in Bedford, MA to support high-quality performance, regulatory compliance, and continuous improvement across manufacturing processes. The role leads CAPA, PFMEA, non-conformance handling, and validation activities in a fast-paced medical device environment.

You will apply data analytics to trends and metrics, drive cross-functional collaboration, and deliver training on quality standards to elevate operational excellence on-site.

Qualifications

• Minimum 5+ years in FDA-regulated medical device quality operations.
• ASQ-CQE and ISO Lead Auditor certifications are desirable.
• Experience with CAPA, PFMEA and non-conformance management.

Responsibilities

• Monitor operations performance, reporting, improvement and development in factories.
• Lead non-conformance investigations and CAPA actions, guide disposition decisions.
• Oversee validation protocols and production builds to support validation activities.
• Ensure quality systems, environmental monitoring and process improvements are maintained.

Skills

Quality operations

CAPA

PFMEA

Change management

Data analytics

Validation

Regulatory compliance

Cross-functional leadership

Education

Bachelor’s Degree in Engineering

Job description

Philips is seeking a Senior Quality Operations Engineer in Bedford, MA to support high-quality performance, regulatory compliance, and continuous improvement across manufacturing processes. The role leads CAPA, PFMEA, non-conformance handling, and validation activities in a fast-paced medical device environment.

You will apply data analytics to trends and metrics, drive cross-functional collaboration, and deliver training on quality standards to elevate operational excellence on-site.