Process Quality Engineer (Onsite in Latham, New York)
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. You’re the right fit if: You’ve acquired some experience in related Quality Engineering functions in the medical device industry preferred, or other regulated industries required (aerospace, defense, automotive, etc.) . You have experience and familiarity with ISO 13485. Your skills include 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. You have a bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent. Lean Six Sigma certification preferred but not required. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You’re an 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. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an onsite role, requiring five days per week onsite in Latham.
Requirements
- experience in related Quality Engineering functions in the medical device industry preferred, or other regulated industries required (aerospace, defense, automotive, etc.)
- experience and familiarity with ISO 13485
- 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
- bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent
- 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
Nice To Haves
- Lean Six Sigma certification preferred but not required
Responsibilities
- 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
- 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).
Benefits
- Employees are eligible to participate in our 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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
