Process Quality Engineer (Onsite in Latham, New York)

Philips•Latham, NY

5d•$87,000 - $139,200•Onsite

About The Position

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. 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.
Working with statistical analyses tools.
Strong ability to support Nonconformances, CAPA’s, process documentation, Measurement System Analysis, Test Method Validations, and Design History Review.
Bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent.
Excellent communicator with an ability to work well cross functionally, and adapt to changing priorities.

Nice To Haves

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

Responsibilities

Ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures.
Verifies products meet requirements before distribution.
Leads ongoing quality and process improvements.
Optimizes production within an area by creating and executing accurate and effective documentation compliant with GDP.
Documents and tracks nonconformances.
Supports problem-solving and continuous improvement activities.
Maintains 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).