Senior Quality Systems Engineer - QMS & Compliance Lead

Philips; Tennessee; On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO

401k

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Quality Systems Engineer to own and optimize the QMS, drive audits, document control, training and CAPA programs, and ensure compliance with FDA/ISO 13485 standards.

You will analyze QMS metrics, develop SOPs and quality manuals, lead cross-functional teams, and prepare for external audits. This office-based role requires on-site presence and a strong background in medical device quality operations.

Qualifications

• Minimum 5+ years in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience documenting QMS changes, gap assessments, audits, document control, training and CAPAs.
• Strong data analysis and KPI reporting capabilities.

Responsibilities

• Own Quality processes including Audits, Document Control, Training, CAPA ensuring QMS efficiency and regulatory compliance.
• Analyze QMS metrics and prepare reports highlighting trends, deviations and improvement areas for senior management.
• Develop, implement and revise QMS processes, SOPs, work instructions and quality manuals for accuracy and compliance.
• Conduct risk assessments to identify regulatory and QMS risks and develop mitigation strategies.
• Lead cross-functional problem solving to address QMS issues using structured methodologies.
• Participate in external regulatory audits and inspections, ensuring documentation readiness and audit responses.

Skills

QMS ownership

Audits

Document control

CAPA management

Data analysis

Root cause analysis

Training metrics

Cross-functional leadership

Regulatory awareness

Education

Bachelor’s Degree in Quality/Engineering

Job description

Philips in Bedford, MA seeks a Senior Quality Systems Engineer to own and optimize the QMS, drive audits, document control, training and CAPA programs, and ensure compliance with FDA/ISO 13485 standards.

You will analyze QMS metrics, develop SOPs and quality manuals, lead cross-functional teams, and prepare for external audits. This office-based role requires on-site presence and a strong background in medical device quality operations.