Senior Quality Systems Engineer: QMS Lead & Compliance

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

Job summary

Philips is seeking a Senior Quality Systems Engineer in Bedford, MA to maintain a compliant QMS and drive continuous improvement. Responsibilities include managing audits, document control, training, CAPA, and SOP development, with strong focus on risk assessment and cross-functional collaboration.

The role requires 5+ years in FDA/ISO 13485 environments, a Bachelor’s degree, and preferable ASQ-CQE or ISO Lead Auditor credentials. This is an office-based position in Bedford, MA.

Qualifications

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

Responsibilities

• Own Quality processes: Audits, Document Control, Training, CAPA.
• Analyze QMS metrics, prepare reports, present trends to management.
• Develop and revise SOPs, work instructions, and quality manuals.
• Perform risk assessments and mitigation planning for regulatory compliance.
• Lead cross-functional problem-solving and root cause analysis sessions.
• Prepare for external regulatory audits and respond to findings with stakeholders.

Skills

QMS compliance

Audits

Document Control

CAPA

Data analysis

KPI tracking

Root cause analysis

Training

Education

Bachelor's Degree

ASQ-CQE (desirable)

ISO Lead Auditor (desirable)

Job description

Philips is seeking a Senior Quality Systems Engineer in Bedford, MA to maintain a compliant QMS and drive continuous improvement. Responsibilities include managing audits, document control, training, CAPA, and SOP development, with strong focus on risk assessment and cross-functional collaboration.

The role requires 5+ years in FDA/ISO 13485 environments, a Bachelor’s degree, and preferable ASQ-CQE or ISO Lead Auditor credentials. This is an office-based position in Bedford, MA.