About this role
This role supports sustaining and new product development activities by partnering with suppliers to improve and verify manufacturing quality. You will evaluate quality issues, manage corrective actions, and lead supplier audits and documentation deliverables to protect patient safety.
Key Responsibilities
- Evaluate and communicate quality issues to suppliers
- Review/approve supplier corrective action plans and verification of effectiveness
- Plan and lead supplier audits for regulatory compliance
- Investigate complaints and manage NCEPs at suppliers
- Lead NPD quality deliverables including quality plans, component qualifications, design verification/validations, and process validations
Technical Overview
The technical scope is supplier quality management across acquired entity integration, including corrective action plan review/approval and verification effectiveness, audit planning/reporting, and executing quality deliverables for NPD such as quality plans, component qualifications, and design/process validations.
Ideal Candidate
The ideal candidate is a senior-level supplier quality engineer experienced in sustaining engineering and new product development within medical device manufacturing. They have led supplier audits, evaluated quality issues, and managed corrective actions and verification of effectiveness, with strong familiarity with regulatory compliance and quality system deliverables.
Must-Have Skills
support supplier corrective action planslead execution of supplier auditsgenerate and review quality plansagreementsproduct specificationscomponent qualificationsdesign verification/validationsand process validations
Required Skills
supplier auditssupplier corrective action plansverification of effectiveness documentationsustaining engineeringprocess change impact managementdesign change implementationNCEPsNew Product Development (NPD)quality planscomponent qualificationsdesign verification/validationsprocess validationsFinished Good Documentation changessupplier change impact assessmentsproject planningcontingency plans
Hard Skills
quality issue evaluationsupplier corrective action plansverification of effectiveness documentationsustaining engineeringprocess change impact managementdesign change implementationsquality systemhybridized BSC-Acquired Entity Quality SystemAcquired Entity Quality systemBoston Scientific Quality Systemsupplier capability assessmentson-site visitstechnical discussionssupplier auditsaudit schedulingaudit observation and findings reportingfollow-up actions confirmationField Action and Product Inquiry ReportsNCEPsNew Product Development (NPD)material controls quality deliverablesquality plansproduct specificationscomponent qualificationsdesign verification/validationsprocess validationsFinished Good Documentation changessupplier change impact assessmentsproject planningproject milestonescontingency plans
Soft Skills
primary commitment to patient safetycollaboration with cross-functional resourcescommunicating quality issuessystematic problem-solvingcoordinationleadershipproject planning and contingency planningstakeholder management
Keywords for Your Resume
Senior Supplier Quality EngineerSupplier Quality EngineerGlobal Sourcingsupplier corrective action plansverification of effectivenesssustaining quality issuesprocess change impactsdesign change implementationsAcquired Entity Quality systemBSC Quality Systemsupplier capabilitieson-site visitssupplier auditsregulatory standardsBoston Scientific requirementsaudit schedulingaudit observation and findingsfollow-up actionsField Action and Product Inquiry ReportsNCEPsFinished Good Documentation changesSupplier Change Impact AssessmentsNew Product Development (NPD)material controls quality deliverablesquality plansproduct specificationscomponent qualificationsdesign verification/validationsprocess validationsproject planscontingency planspatient safetyElutia acquisition
Deal Breakers
Demonstrated experience as a supplier quality engineer (supplier audits, corrective action plans, and NCEPs)
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