Hybrid QMS Specialist for Medical Devices (ISO 13485)

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

Benefits offered by this job

401(k) match

Paid time off

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 regulatory and international standards, manage documentation and DHR reviews, and execute change control to support a robust QMS.

The role requires experience with TrackWise/EtQ and SAP, plus strong analytics for KPI reporting. The incumbent will contribute to training content, drive process improvements, and ensure document control across local policies.

Qualifications

• 4+ years of experience in Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.
• ISO 9001:2015 / ISO 13485:2016 / GMP knowledge.
• Strong communication and organizational skills, with ability to multi-task and prioritize workload.

Responsibilities

• Ensure Latham site complies with Philips Excellence Process Framework (PEPF) and ICQA requirements.
• Manage local QMS processes and documentation control, including DHR reviews.
• Plan and monitor internal/external audits and drive corrective actions.
• Develop and contribute to training content for local QMS documents and report KPI data to measure QMS effectiveness.

Skills

QMS

Regulatory compliance

Data analysis

Education

Bachelor's Degree in Mechanical Engineering

Industrial Engineering

Science

Tools

TrackWise

EtQ

SAP

Job description

Philips in Latham, NY is seeking a QMS Specialist to join the Operations Quality team. You will ensure compliance with regulatory and international standards, manage documentation and DHR reviews, and execute change control to support a robust QMS.

The role requires experience with TrackWise/EtQ and SAP, plus strong analytics for KPI reporting. The incumbent will contribute to training content, drive process improvements, and ensure document control across local policies.