Process Quality Engineer

Responsibilities

• Ensure facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures.
• Optimize production by creating and executing accurate documentation compliant with Good Documentation Practices (GDP).
• Document and track nonconformances, supporting problem-solving and continuous improvement activities.
• Manage Quality Management System (QMS) requirements, including change control, deviations, PFMEAs, control plans, and CAPAs.
• Verify that products meet all requirements before distribution.
• Maintain documentation verifying effective On the Job Training (OJT) of operators.
• Work closely with Area Managers, Team Leads, and Manufacturing Engineers to drive process improvements.

Requirements

• 2+ years of Quality Engineering experience in the medical device industry or other regulated industries (aerospace, defense, automotive).
• Strong knowledge of ISO 13485 standards.
• Proven experience with process and manufacturing equipment validation, PFMEAs, and control plans.
• Proficiency with statistical analysis tools.
• Experience supporting Nonconformances, CAPAs, Measurement System Analysis, and Test Method Validations.
• Bachelor’s degree in Mechanical Engineering, Electronics Engineering, Science, or an equivalent field.
• Ability to work onsite five days per week in Latham, NY.

Preferred Qualifications

• Lean Six Sigma certification.
• Experience in transformational or change management roles.

Benefits

• Comprehensive Philips Total Rewards program.
• Generous Paid Time Off (PTO).
• 401k with up to 7% match.
• Health Savings Account (HSA) with company contribution.
• Stock purchase plan and education reimbursement.

About the Company

Philips is a global health technology company dedicated to improving people's health and wellbeing through meaningful innovation. For over 130 years, we have focused on advancing technology in areas such as Precision Diagnosis, Image Guided Therapy, and Connected Care to ensure better healthcare access for everyone.