Supplier Quality Engineer

Supplier Quality Engineer

QA Engineer Marlborough, MA Healthcare JO-1905-1229

Supplier Quality Engineer is needed to assist our client with their EU MDR initiative. The SQE should be capable of ensuring Client's Suppliers are compliant with both EU MDR and Client's process/deliverables. The SQE will assess and qualify each Supplier, via objective evidence, that the Supplier's processes consistently produce a result or product that meets EU MDR and any other specifications identified during the project.

Duties / Expectations of Role

• Assist in the identification of sourcing the project scope and identification of in-scope suppliers
• Assist in qualification of identified Suppliers via project-defined Corporate Supplier Qualification Process (including closing of warrants and archiving of project documentation)
• Qualify each in-scope Supplier (to meet EU MDR via project-defined Supplier Qualification Process) and associated deliverables
• Client requests, receives reviews, accept/reject supplier documentation until fulfillment of EU MDR requirements are met and meet process requirements
• Implement, communicate, execute, receive, review, track, report, and archive all documentation as objective evidence as requested for purpose of compliance to EU MDR, Corporate Procedures, 21 CFR Part 820.50 and 21 CFR Part 820.120
• Ensure that suppliers are EU MDR compliant via objective evidence/documentation gathered over the course of the project using Client supplier qualification process such as SPPA/PPA

Mandatory Requirements

• 8- 10 years' experience as a supplier quality engineer in the medical device industry
• Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols
• Must have strong skill set or evidence of ability to work without supervision yet meet project milestone dates/deliverables
• Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA
• Experience in pFMEA, manufacturing process flows, control plans, and quality records

Nice to Have Requirements

• UDI and medical device labelling/marking, quality system remediation, and ability to positively interfacing with the company's suppliers