Supplier Quality Engineer Entegee - 3.7 Hamden, CT Job Details Full-time | Contract $47 - $49 an hour 3 hours ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Sourcing Teamwork Production risk assessment Supplier audits Supplier audit compliance assessment Production validation processes Biomedical regulatory compliance

FMEA PPAP

Test validation method Supplier risk evaluation

ISO 13485

Cross-functional communication FDA regulations Full Job Description Job Summary We are seeking a Supplier Quality Engineer to manage finished goods produced by contract manufacturers for robotic surgical technologies. This role owns all QMS-related activities tied to supplier selection, supplier change requests, part and process qualification, and ongoing quality, service, and cost improvements. You will partner with new and existing contract manufacturers to develop, implement, and maintain technical quality assurance systems, and serve as the quality authority between suppliers and internal engineering, sourcing, and operations teams. Responsibilities Lead, review, and approve supplier change requests (SCR), validations, test method validations (TMV), PPAP, and supplier corrective actions (SCAPA) Support supplier selection and qualification for contract-manufactured finished goods Develop, implement, and maintain quality assurance systems with suppliers, including MSAs, quality plans, control plans, and FMEAs Drive QMS development and continuous improvement across contract manufacturers Perform risk management and risk assessments for supplier-related changes and processes Monitor supplier performance and lead technical quality, service, and cost improvement initiatives Ensure supplier compliance with

ISO 13485, 21 CFR

820, and internal quality requirements Requirements Bachelor's degree in Engineering, Scientific, Electronic, or a related technical field Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years Medical device supplier quality experience required Hands-on experience with SCR, validation, TMV, PPAP, SCAPA, and QMS development Experience with supplier selection and qualification Strong knowledge of ISO 13485 and 21 CFR 820 Risk management and risk assessment experience Strong communication and cross-functional collaboration skills U.S. citizenship required #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:

$47.00 - $49.00 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:

Hybrid remote in Hamden, CT 06518