QMS Manager - Quality & Compliance Leader (Hybrid)

Philips; Cambridge (MA); On-site; USD 102,000 - 143,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Philips in Cambridge, MA is seeking a QMS Manager to lead the Quality Management System team and ensure compliant execution of quality processes across the organization.

You will supervise daily QMS operations, oversee document control, training, internal audits, and CAPA activities, and drive risk assessments. This office/remote role requires strong leadership and a focus on continuous improvement.

Qualifications

• 3+ years of experience with Bachelor's in areas such as Quality Engineering, Quality Management Systems, Process Engineering or equivalent.
• 5+ years of experience with medical device regulations and standards, QMS Management, QMS Remediation, Host Quality Audits, CAPA, Root Cause Analysis, Data Analysis.

Responsibilities

• Supervises day-to-day operations of the QMS team, ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements.
• Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits.
• Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps.
• Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing responses to audit findings.
• Conducts risk assessments and manages risk mitigation activities.

Skills

QMS management

CAPA

Root cause analysis

Data analysis

Education

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent

Job description

Philips in Cambridge, MA is seeking a QMS Manager to lead the Quality Management System team and ensure compliant execution of quality processes across the organization.

You will supervise daily QMS operations, oversee document control, training, internal audits, and CAPA activities, and drive risk assessments. This office/remote role requires strong leadership and a focus on continuous improvement.