Summary Senior Supplier Quality Engineer responsible for supplier controls, new product development, design transfer, risk management, validation, and quality system compliance throughout the medical device product lifecycle. Job Requirements Bachelor's degree in Engineering. 4+ years of relevant supplier quality or medical device quality engineering experience. Experience with new product development (NPD). Experience with design transfer to suppliers. Experience managing supplier changes. Experience with supplier nonconformances. Experience with Corrective and Preventive Action (CAPA) activities. Experience with Nonconformance Reports (NCRs). Knowledge of risk management requirements in accordance with

ISO 14971.

Experience with process validation, including IQ, OQ, and PQ. Experience supporting verification and validation activities. Experience with supplier controls in a regulated medical device environment. Experience supporting product design, development, and sustaining engineering activities. Preferred Skills Experience serving as the supplier quality representative on cross-functional product development teams. Experience with supplier qualification and monitoring. Experience supporting regulatory and quality system compliance for medical devices. Experience with supplier-related risk assessments. Experience supporting sustaining engineering changes. Experience with design verification, design validation, and supplier process validation. Job Responsibilities Provide supplier quality engineering support throughout the medical device product lifecycle. Support new product development and design transfer activities involving external suppliers. Review and approve supplier-related design, process, and manufacturing changes. Manage supplier nonconformances and corrective action activities. Lead or support CAPA investigations involving supplier-related issues. Support NCR evaluation, disposition, and closure. Perform supplier risk assessments in accordance with

ISO 14971.

Support process validation activities, including IQ, OQ, and PQ. Support verification and validation activities for supplied components and processes. Develop and maintain supplier control strategies. Support supplier qualification, approval, and ongoing performance monitoring. Evaluate supplier capability for product design and manufacturing requirements. Support sustaining engineering changes affecting supplied components or processes. Maintain supplier quality documentation within applicable quality systems. Ensure supplier quality activities comply with applicable medical device regulatory and quality requirements. #GRPB Equal Opportunity Employer/Veterans/Disabled. Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records .

Pay:

$56.00 - $59.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

In person