Process Quality Engineer (Onsite in Latham, New York)

Process Quality Engineer (Onsite Latham, New York) The Process Quality Engineer at Latham ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures. They verify products meet requirements before distribution and lead ongoing quality and process improvements. Responsibilities The Process Quality Engineer (QE) is a member of the Operations Quality team in Latham and works closely with Area Managers, Team/Group Leads, and Manufacturing Engineers to optimize production within an area by creating and executing accurate and effective documentation compliant with GDP, documenting and tracking nonconformances, supporting problem‑solving and continuous improvement activities, and maintaining documentation verifying effective On the Job Training (OJT) of operators. Ensures that executed processes meet the requirements of the site’s QMS, including but not limited to creation of Quality Data Sheets, change control, deviations, nonconformances, PFMEAs/control plans, Device History Records, and CAPAs. Reports to the Latham Operations Quality Manager and works closely with the Operations team responsible for area oversight, aligning with the Operations Quality team to ensure compliance, consistency and efficiency throughout the organization. Collaborates with other Quality, Manufacturing, and Design Engineers on a site that has led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems. Requires onsite presence five days per week. Qualifications 2+ years of related Quality Engineering experience in the medical device industry preferred, or other regulated industries (aerospace, defense, automotive, etc.); strong experience with ISO 13485; ability to act as a change agent in similar environments. Strong process and manufacturing equipment validation experience, PFEMA’s, control plans, and statistical analysis tools; ability to support nonconformances, CAPAs, process documentation, measurement system analysis, test method validations, and design history review. Bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent; Lean Six Sigma certification preferred but not required. Must be able to successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodation. Excellent communicator capable of working cross‑functionally and adapting to changing priorities; up to 10% travel required. Location and Travel Onsite role requiring full-time presence in the company’s facilities, five days per week in Latham, New York. Up to 10% travel may be required based on business needs. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa. Company relocation benefits will not be provided for this position; candidates must reside within commuting distance to Latham, NY. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. #J-18808-Ljbffr Philips Iberica SAU