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Process Quality Assurance Specialist
2 months ago
The Process Quality Engineer plays a critical role in ensuring the facility operates in compliance with its established Quality Management System (QMS), confirming product compliance according to applicable standards and requirements prior to distribution to Philips system manufacturing facilities and customer sites.
Key Responsibilities- Ensures that executed processes meet the requirements of the site's QMS, including but not limited to: the creation of Quality Data Sheets (Data Collects), change control, deviations, non-conformances, PFMEAs/control plans, Device History Records (DHRs) and Corrective and Preventive Actions (CAPAs).
- Works closely with Area Managers, Team/Group Leads and Manufacturing Engineers (MEs) to optimize production within an area by creating and executing accurate and effective documentation compliant to medical device regulations and standards.
- Documents, manages, and monitors non-conformances, leads problem-solving and continuous improvement activities, and maintains documentation verifying effective On the Job Training (OJT) of operators.
- 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.
We are a health technology company committed to improving the lives of others. Our purpose is to make a meaningful difference in people's lives through our innovative solutions and products. We believe that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
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. We are an equal opportunity employer and welcome applications from diverse candidates.
