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About the Role

The Process Quality Engineer (QE) is a member of the Operations Quality team in Latham, working closely with Area Managers, Team/Group Leads, and Manufacturing Engineers (MEs) to optimize production. This role involves creating and executing compliant documentation, documenting and tracking nonconformances, supporting problem-solving and continuous improvement, and maintaining training documentation. The QE ensures executed processes meet QMS requirements, including Quality Data Sheets, 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 Manager and collaborates with Operations and Quality teams for compliance, consistency, and efficiency. The role offers the opportunity to work with other engineers on innovative MRI magnet design.

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.
Creates and executes 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 executed processes meet QMS requirements, including Quality Data Sheets, change control, deviations, nonconformances, PFMEAs/control plans, Device History Records (DHRs), and Corrective and Preventive Actions (CAPAs).

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.
Experience with transformational or change management roles in similar environments.
Strong process and manufacturing equipment validation experience.
Experience with PFMEAs, 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.
Must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
Excellent communicator with an ability to work well cross functionally.
Ability to adapt to changing priorities.
Requires up to 10% travel as required by business needs.
Reside in or within commuting distance to Latham, NY.

Skills

Process and manufacturing equipment validation
PFMEA
Control plans
Statistical analyses tools
Nonconformances
CAPA's
Process documentation
Measurement System Analysis
Test Method Validations
Design History Review
ISO 13485
GDP
Change management

Location

Latham, New York

Work Type

Onsite
Full-time

Experience Level

2+ years

Education Level

Bachelor's degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent
Lean Six Sigma certification preferred

Salary/Compensations

$87,000 to $139,200

Benefits

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

About the Company

Philips is a health technology company focused on improving people’s health and wellbeing through meaningful innovation.
For more than 130 years, Philips has been creating technologies and innovations that improve people's lives and support healthcare practitioners.
Headquartered in the Netherlands and operating in more than 100 countries globally, Philips focuses on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
Philips is committed to fostering a culture where all are treated with respect and professionalism.

Equal Opportunity

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law.