Philips Process Quality Engineer 

United States, New York, New York 

311627213

Process Quality Engineer
Job Description

The Process Quality Engineer ensures 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.

In this role you will be responsible for:

• 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 (MEs) to optimize production within an area by creating and executing accurate and effective documentation compliant to medical device regulations and standards, documenting, managing, and monitoring nonconformances, leading 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: the creation of Quality Data Sheets (Data Collects), change control, deviations, nonconformances, PFMEAs/control plans, Device History Records (DHRs) and Corrective and Preventive Actions (CAPAs).

• This position reports to the Latham Operations Quality Engineering Manager. The employee will work closely with the Operations team responsible for the area of oversight, while aligning with the Operations Quality team to ensure compliance, consistency and efficiency throughout the organization.

• This employee will be required to work closely with other Quality, Manufacturing, Procurement, and Design Engineers on a site that have led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems. This position requires the employee to be on site five days per week.

You're the right fit if:

• You’ve have quality engineering experience in medical device (preferred) or a regulated industry (e.g. aerospace, automotive).

• You have 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). Must be proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) MES software desired.

• You’re an individual with strong communication skills including written, verbal and listening; and have excellent organizational skills with the ability to multi-task and effectively prioritize your workload.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re 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. Learn more about our commitment to diversity and inclusion .

For this position, you must be willing to live in or reside within commuting distance to