Process Quality Assurance Specialist

6 days ago


Latham, New York, United States Philips North America Full time
Job Title: Process Quality Engineer

At Philips North America, we are seeking a highly skilled Process Quality Engineer to join our team. As a key member of our Operations Quality team, you will play a critical role in ensuring the facility operates in compliance with its established Quality Management System (QMS).

Key Responsibilities:
  • Ensure that executed processes meet the requirements of the site's QMS, including the creation of Quality Data Sheets, change control, deviations, nonconformances, PFMEAs/control plans, Device History Records, and Corrective and Preventive Actions.
  • Collaborate with Area Managers, Team/Group Leads, and Manufacturing Engineers to optimize production within an area by creating and executing accurate and effective documentation compliant to medical device regulations and standards.
  • Document, manage, and monitor nonconformances, lead problem-solving and continuous improvement activities, and maintain documentation verifying effective On the Job Training (OJT) of operators.
Requirements:
  • Quality engineering experience in medical device or a regulated industry (e.g., aerospace, automotive).
  • Experience working in a Quality Management System compliant with ISO 9001, ISO 13485, and/or FDA CRF 21 part 820, and Good Manufacturing Practices (GMP).
  • Proficiency with Microsoft Office applications and experience with eQMS (Trackwise, EtQ) and ERP (SAP) MES software desired.
About Philips North America:

We are a health technology company dedicated to improving the lives of others. Our mission is to provide quality healthcare solutions that make a meaningful difference in people's lives. If you're passionate about quality and committed to excellence, we encourage you to apply for this exciting opportunity.

Compensation and Benefits: The pay range for this position is $79,800 to $136,800 annually. In addition to a competitive salary, we offer a comprehensive benefits package, including a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and much more.

Equal Employment Opportunity: Philips North America is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.



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