QMS & Compliance Specialist – Medical Devices

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

Job summary

Philips Iberica SAU is seeking a QMS Specialist to join the Operations Quality team in Latham, NY. You will ensure compliance with regulatory standards, manage documentation, and drive QMS improvements to enable controlled change.

The role requires a Bachelor's or equivalent, 4+ years of QMS and audits experience in regulated industries, plus proficiency with MS Office and eQMS/SAP. Onsite with 3 days in office guidance.

Qualifications

• Vocational Education or Bachelor's degree in Mechanical/Industrial Engineering or Science.
• 4+ years of experience in Quality Management Systems and Quality Audits in highly regulated environments.
• 3+ years of experience with QMS in medical devices; knowledge of ISO 9001:2015 / ISO 13485:2016 / GMP; regulatory data analysis.
• Strong communication and organizational skills; proficient with MS Office; experience with eQMS and ERP software.

Responsibilities

• Manage local QMS processes and ensure process leveraging compliance capabilities.
• Manage DHR review process; ensure Q&R requirements are effective in all processes.
• Document Control management for all policies and local documentation; monitor periodic review.
• Ensure audit planning and scheduling meets internal and external regulatory requirements.
• Support training and training administration according to QMS; contribute to local QMS document content.
• Collect and report metrics/KPI data to measure QMS effectiveness.

Skills

Quality management

Regulatory compliance

Quality audits

Document control

Communication skills

MS Office

TrackWise

Education

Bachelor's degree in Mechanical Engineering/Industrial Engineering/Science or equivalent

Tools

TrackWise

EtQ

SAP

Job description

Philips Iberica SAU is seeking a QMS Specialist to join the Operations Quality team in Latham, NY. You will ensure compliance with regulatory standards, manage documentation, and drive QMS improvements to enable controlled change.

The role requires a Bachelor's or equivalent, 4+ years of QMS and audits experience in regulated industries, plus proficiency with MS Office and eQMS/SAP. Onsite with 3 days in office guidance.