Process Quality Engineer (Onsite in Latham, New York)

Philips•Latham, NY

13d•$87,000 - $139,200•Onsite

About The Position

Process Quality Engineer (Onsite- Latham, NY) The Process Quality Engineer at Latham ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures. They also verify products meet requirements before distribution and lead ongoing quality and process improvements. Your role: 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 with GDP, documenting and tracking nonconformances, supporting 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 into the Latham Operations Quality Manager. The employee will work closely with the Operations team responsible for his/her area of oversight, while aligning with the Operations Quality team to ensure compliance, consistency and efficiency throughout the organization. This employee will have the opportunity to work closely with other Quality, Manufacturing and Design Engineers on a site that has led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems. This position requires the employee to be onsite five days per week.

Requirements

2+ years of related Quality Engineering experience in the medical device industry preferred, or other regulated industries required (aerospace, defense, automotive, etc.)
Strong experience with and understanding of ISO 13485 preferred
Strong process and manufacturing equipment validation experience, PFMEA’s, control plans, and working with statistical analyses tools
Strong ability to support Nonconformances, CAPA’s, process documentation, Measurement System Analysis, Test Method Validations, and Design History Review, among other things is required
Bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
Excellent communicator with an ability to work well cross functionally, and adapt to changing priorities
Requires up to 10% travel as required by business needs
US work authorization is a precondition of employment
Must reside in or within commuting distance to Latham, NY

Nice To Haves

The ideal candidate will be a change agent and have experience with transformational or change management roles in similar environments previously.
Lean Six Sigma certification preferred but not required.

Responsibilities

Creating and executing accurate and effective documentation compliant with GDP
Documenting and tracking nonconformances
Supporting problem-solving and continuous improvement activities
Maintaining documentation verifying effective On the Job Training (OJT) of operators
Ensuring 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).

Benefits

comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

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