Process Quality Assurance Specialist

1 week ago


Latham, New York, United States Philips Full time
About the Role

We are seeking a highly skilled Process Quality Engineer to join our team at Philips. 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
  • Develop and execute accurate and effective documentation compliant to medical device regulations and standards.
  • Document, manage, and monitor nonconformances, leading problem-solving and continuous improvement activities.
  • Maintain documentation verifying effective On the Job Training (OJT) of operators.
  • Ensure executed processes meet the requirements of the site's QMS, including Quality Data Sheets (Data Collects), change control, deviations, nonconformances, PFMEAs/control plans, Device History Records (DHRs), and Corrective and Preventive Actions (CAPAs).
Requirements
  • Quality engineering experience in medical device (preferred) 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).
  • Proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) MES software desired.
  • Strong communication skills, including written, verbal, and listening; and excellent organizational skills with the ability to multi-task and effectively prioritize your workload.
About Philips

We are a health technology company committed to improving the lives of others. Our purpose is to make a meaningful difference in the lives of patients, customers, and employees. We are dedicated to innovation and excellence in all aspects of our business.

At Philips, we value diversity and inclusion. We are an equal opportunity employer and welcome applications from qualified candidates from diverse backgrounds. If you are interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips.

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. Details about our benefits can be found here.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

This position requires the employee to be on site five days per week. The pay range for this position is $79,800 to $136,800 annually. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.



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