QMS Manager

Philips•Cambridge, MA

6d•$102,000 - $143,400•Hybrid

About The Position

In this role you are responsible for supervising the QMS team, ensuring efficient execution of quality management system (QMS) activities in compliance with company policies. Your role includes supervising day-to-day operations of the QMS team, managing the deployment and maintenance of QMS processes, monitoring and reporting on the effectiveness of QMS processes, preparing for and supporting external audits and inspections, and conducting risk assessments and managing risk mitigation activities.

Requirements

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
3+ years of experience with Bachelor's in areas such as Quality Engineering, Quality Management Systems, Process Engineering or equivalent.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

5+ years of experience with medical device regulations and standards, QMS Management, QMS Remediation, Hosting 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.
Guides and mentors the QMS team, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes.
Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits, ensuring they are effective, compliant, and aligned with both regulatory requirements and business needs.
Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps, enhance compliance, and improve overall quality.
Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
Manages the documentation and resolution of non-conformance reports (NCRs), ensuring systematic tracking, effective resolution, and implementation of preventive measures to avoid recurrence.
Conducts risk assessments and manages risk mitigation activities, identifying potential risks to product quality and QMS integrity, and developing strategies to minimize their impact.