QMS Compliance Lead – Medical Devices & Audits

Philips; Latham (NY); On-site; USD 63,000 - 100,000; Full time

Benefits offered by this job

PTO

401k match

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips in Latham, NY is seeking a QMS Specialist to join the Operations Quality team. You will ensure compliance with PEFP, ICQA and regulatory standards, manage documentation, and drive QMS improvements to execute changes in a controlled manner.

You will oversee local QMS processes, DHR reviews, audit planning, and KPI reporting. Strong knowledge of ISO 9001/13485, GMP, and tools like Trackwise/EtQ/SAP is required.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 4+ years in Quality Management Systems in highly regulated environments (MD, Pharma, Automotive).
• 3+ years of QMS experience in medical devices; knowledge of ISO 9001:2015 / ISO 13485:2016 / GMP.

Responsibilities

• Ensure site activities comply with Philips Excellence Process Framework (PEPF), ICQA, and regulatory requirements.
• Manage (local) QMS processes and ensure process leveraging compliance capabilities.
• Oversee DHR review, Q&R requirements, document control for policies and local docs; monitor periodic reviews.
• Plan audits and ensure they meet internal policies and external regulations.
• Support training and training administration; collect and report KPI data to measure QMS effectiveness.

Skills

Communication

Organizational skills

Multitasking

Microsoft Office

SAP

Education

Mechanical/Industrial Engineering or Science degree

Tools

Trackwise

EtQ

SAP ERP

Job description

Philips in Latham, NY is seeking a QMS Specialist to join the Operations Quality team. You will ensure compliance with PEFP, ICQA and regulatory standards, manage documentation, and drive QMS improvements to execute changes in a controlled manner.

You will oversee local QMS processes, DHR reviews, audit planning, and KPI reporting. Strong knowledge of ISO 9001/13485, GMP, and tools like Trackwise/EtQ/SAP is required.