The Process Quality Engineer ensures the facility operates in compliance with its established Quality Management System (QMS), confirming product compliance according to applicable standards and requirements prior to distribution to Philips system manufacturing facilities and customer sites.In this role you will be responsible for:
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 to medical device regulations and standards, documenting, managing, and monitoring nonconformances, leading 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 Engineering Manager. The employee will work closely with the Operations team responsible for the area of oversight, while aligning with the Operations Quality team to ensure compliance, consistency and efficiency throughout the organization.
This employee will be required to work closely with other Quality, Manufacturing, Procurement, and Design Engineers on a site that have led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems. This position requires the employee to be on site five days per week.
You're the right fit if:
You’ve acquired 5+ years of Quality engineering experience in medical device (preferred) or a regulated industry (e.g. aerospace, automotive).
You have experience working in a Quality Management System compliant with ISO 9001, ISO 13485, and/or FDA CRF 21 part 820, and Good Manufacturing Practices (GMP). Must be proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) MES software desired.
You have a Bachelor’s Degree in an engineering discipline with 5 years relevant experience, or an Associate’s Degree or technical certification with 10+ years relevant work experience
You’re an individual with strong communication skills including written, verbal and listening; and have excellent organizational skills with the ability to multi-task and effectively prioritize your workload.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.Philips Transparency DetailsThe pay range for this position is $79,800 to $136,800 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Latham, NY. USAIt is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
Full-time