Quality Systems Manager - Compliance & Audit Lead

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

Job summary

Philips seeks a QMS Manager in Cambridge, MA to lead the quality management system team and drive compliant, efficient QMS operations. You will oversee document control, training, internal audits, NCR resolution, and CAPA activities.

The role involves risk assessment and reporting, with collaboration across functions to ensure regulatory alignment and continuous improvement. The position is office-based in Cambridge with emphasis on hands-on leadership, mentorship, and cross-functional

Qualifications

• 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
• We prefer 5+ years of experience with medical device regulations and standards, QMS Management, QMS Remediation, Hosting Quality Audits, CAPA, Root Cause Analysis, Data Analysis.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

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.

Job description

Philips seeks a QMS Manager in Cambridge, MA to lead the quality management system team and drive compliant, efficient QMS operations. You will oversee document control, training, internal audits, NCR resolution, and CAPA activities.

The role involves risk assessment and reporting, with collaboration across functions to ensure regulatory alignment and continuous improvement. The position is office-based in Cambridge with emphasis on hands-on leadership, mentorship, and cross-functional