Senior QMS Engineer — Quality & Compliance Lead

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

Benefits offered by this job

401k matching

Health insurance

Education reimbursement

Stock purchase plan

Job summary

Philips is seeking aSenior Quality Systems Engineer to ensure a compliant QMS across audits, CAPA, document control, and training. You will analyze QMS metrics, develop and revise SOPs, and lead risk assessments to minimize regulatory risk.

The role requires deep regulatory knowledge and a track record in medical device quality operations. You will mentor engineers, drive continuous improvement, and work with internal and external stakeholders to sustain quality excellence within an office-based

Qualifications

• Minimum 5+ years in FDA/ISO 13485 medical device quality operations/manufacturing environments.
• Experience managing/tracking training metrics.
• Proven ability to mentor engineers and lead cross-functional teams.
• Experience CAPA processes with root cause analysis and preventive actions.
• Strong data analysis skills with KPI reporting.
• Ability to build relationships with stakeholders and suppliers.
• Bachelor’s Degree in Quality/Engineering or similar.
• ASQ-CQE and ISO Lead Auditor certifications desired.

Responsibilities

• Takes ownership of Quality processes including Audits, Document Control, Training, CAPA to ensure a compliant QMS.
• Analyzes QMS metrics and prepares detailed trend/variance reports for senior management.
• Develops, implements and revises QMS processes, SOPs, work instructions, and quality manuals.
• Performs risk assessments to identify regulatory/compliance risks and mitigation strategies.
• Drives continuous improvement initiatives to enhance quality and operational excellence.
• Leads cross-functional problem-solving sessions using root cause analysis.

Skills

Audits

Document Control

CAPA

Training metrics

Cross-functional leadership

Data analysis

Regulatory knowledge

Education

Bachelor's Degree

Tools

ASQ-CQE

ISO Lead Auditor

Job description

Philips is seeking aSenior Quality Systems Engineer to ensure a compliant QMS across audits, CAPA, document control, and training. You will analyze QMS metrics, develop and revise SOPs, and lead risk assessments to minimize regulatory risk.

The role requires deep regulatory knowledge and a track record in medical device quality operations. You will mentor engineers, drive continuous improvement, and work with internal and external stakeholders to sustain quality excellence within an office-based