Senior QMS Lead: Quality, Compliance & Audits

philips; United States; On-site; USD 102,000 - 143,000; Full time

Job summary

Philips, a health technology leader, is seeking a QMS Manager to supervise the QMS team and drive compliant quality processes within our Cambridge MA operations. The role focuses on deploying and maintaining QMS activities, documenting outcomes, and supporting audits.

Office-based work requires visibility and collaboration across multiple functions. The ideal candidate holds a Bachelor’s or Master’s degree in engineering or science and 3+ years in quality domains, with 5+ years in regulated

Qualifications

• Bachelor's or 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.
• 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 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 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.

Skills

Quality Management

CAPA

Root Cause Analysis

Data Analysis

Risk Management

Education

Bachelor's degree in Mechanical/Industrial Engineering or Science

Master's degree in Mechanical/Industrial Engineering or Science

Job description

Philips, a health technology leader, is seeking a QMS Manager to supervise the QMS team and drive compliant quality processes within our Cambridge MA operations. The role focuses on deploying and maintaining QMS activities, documenting outcomes, and supporting audits.

Office-based work requires visibility and collaboration across multiple functions. The ideal candidate holds a Bachelor’s or Master’s degree in engineering or science and 3+ years in quality domains, with 5+ years in regulated