QMS Specialist

About the role

The QMS Specialist is a member of the Operations Quality team in Latham, ensuring compliance with legal, regulatory, and international standards as they apply to Philips’ Quality Management System. This individual is responsible for documentation, process improvement, and execution of QMS procedures and work instructions to ensure changes are executed in a controlled manner and in compliance with applicable regulations.

Responsibilities

• Ensure activities at the Latham site comply with the Philips Excellence Process Framework (PEPF), Intra‑Company Quality Agreements (ICQA), and other applicable regulatory requirements.
• Manage local QMS processes and leverage compliance capabilities.
• Oversee the DHR (Device History Record) review process.
• Ensure Q&R requirements are effective across all scoped processes.
• Manage document control for all policies and local documentation, including periodic documentation review.
• Plan and schedule audits to meet internal policies and external regulations.
• Support training administration per the QMS and contribute to training content for local QMS documents.
• Collect and report metrics/KPI data to measure QMS effectiveness.

Qualifications

• Vocational Education or Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
• 4+ years of experience in Quality Management Systems, quality audits, or equivalent in highly regulated environments such as medical devices, pharma, or automotive.
• 3+ years of experience with QMS in the medical device industry.
• General understanding of ISO 9001:2015, ISO 13485:2016, and Good Manufacturing Practices (GMP).
• Regulatory knowledge and data analysis experience.
• US work authorization (no sponsorship available).
• Must reside in or within commuting distance to Latham, NY.

Skills

• Strong written, verbal, and listening communication skills.
• Excellent organizational abilities with the capacity to multi‑task and prioritize workload.
• Proficiency with Microsoft Office applications.
• Experience with electronic QMS platforms (e.g., TrackWise, EtQ) and ERP systems (e.g., SAP) is desired.

Benefits

• Generous paid time off (PTO).
• 401(k) plan with up to 7% company match.
• Health Savings Account (HSA) with company contribution.
• Employee stock purchase plan.
• Education reimbursement.
• Comprehensive Philips Total Rewards program.

Pay

The pay range for this position in Latham, NY is $63,000 to $100,000 annually. Base pay may vary within this range based on knowledge, skills, experience, business needs, location, and internal equity. Additional compensation such as an annual incentive bonus, sales commission, or long‑term incentives may also be offered.

Schedule

This is an office‑based role. Team members are expected to work in‑person at least three days per week. Full‑time presence in the company’s facilities is required for onsite roles.