Process Quality Engineer (Onsite in Latham, New York) jobs in United States
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Philips · 8 hours ago

Process Quality Engineer (Onsite in Latham, New York)

Philips is a health technology company dedicated to improving access to quality healthcare. They are seeking a Process Quality Engineer to ensure compliance with ISO 13485 and lead quality and process improvements within the Operations Quality team in Latham, NY.

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Responsibilities

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

Qualification

ISO 13485Quality EngineeringProcess ValidationPFMEALean Six SigmaStatistical AnalysisChange ManagementCommunication

Required

2+ years of related Quality Engineering experience in the medical device industry or other regulated industries (aerospace, defense, automotive, etc.)
Strong experience with and understanding of ISO 13485
Strong process and manufacturing equipment validation experience
Experience with PFMEA's, control plans, and working with statistical analyses tools
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
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Excellent communicator with an ability to work well cross functionally and adapt to changing priorities
Ability to travel up to 10% as required by business needs

Preferred

Experience with transformational or change management roles in similar environments
Strong experience with ISO 13485
Lean Six Sigma certification

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement

Company

Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.

Funding

Current Stage
Public Company
Total Funding
$4.23B
Key Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M

Leadership Team

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Neil Mesher
CEO and SVP, UK and Ireland
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Company data provided by crunchbase