{"id":1695197,"url":"https://alion.io/job/deka-research-development-senior-supplier-quality-engineer-deka-research-development","title":"Senior Supplier Quality Engineer - DEKA Research & Development","company":{"id":2016025,"name":"DEKA Research & Development","domain":"dekaresearch.com","url":"https://alion.io/company/dekaresearch","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Manchester, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":82000,"max_usd":156000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5037},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-02T12:01:51Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-12T17:47:43Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives robust supplier qualification, development, and performance management processes.\nThe Sr. SQE serves as a key technical and quality liaison between DEKA, manufacturing partner and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support supplier qualification activities for NPI programs, including process validation support, and onboarding of new suppliers, while also managing sustaining supplier quality performance for production materials and services.\nHow you will make an impact as a Senior Supplier Quality Engineer:\nLead supplier qualification activities for New Product Introduction (NPI) projects\nPerform risk-based supplier assessments aligned with product and process criticality\nSupport supplier selection decisions in collaboration with Design Authority (customer), Engineering, Procurement, and Quality Assurance\nConduct supplier audits (remote and onsite) for new and existing suppliers\nReview and approve supplier documentation including certifications, validations, and quality records\nEnsure supplier readiness for production launch, including capacity, quality systems, and process controls\nParticipate in design transfer and process validation activities where supplier input is required\nSustaining Supplier Quality ManagementOwn supplier quality oversight for assigned NPI projects and production suppliers\nMonitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)\nLead supplier corrective action activities (SCAR/CAPA) and ensure timely closure\nConduct supplier performance reviews and drive continuous improvement initiatives\nSupport containment, root cause analysis, and resolution of supplier-related quality issues\nPerform risk-based supplier re-evaluations and periodic assessments\nSupplier Quality System & ComplianceEnsure supplier compliance with applicable regulatory and quality system requirements including ISO 13485\nMaintain and improve Approved Supplier List (ASL) classification and risk-based controls\nSupport external and internal audits involving supplier quality systems\nEnsure supplier quality agreements are established and maintained\nDrive adherence to change notification and supplier control requirements\nCross-Functional CollaborationPartner with Design Authority (customer), Procurement, Manufacturing and Engineering\nSupport material nonconformance investigations and disposition decisions\nProvide supplier risk input to project teams and change control processes\nSupport supply continuity and risk mitigation strategies\n Skills you will need to be successful in this role:Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree. \n3-5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry\nStrong knowledge of ISO 13485 and medical device regulatory requirements\nExperience with supplier audits, qualification, and risk-based supplier management\nExperience supporting NPI or design transfer activities strongly preferred\nStrong understanding of manufacturing processes, validation, and quality systems.\nSkills & CompetenciesExperience with contract manufacturing and global supply chains\nAbility interpret mechanical drawings (CAD files)\nFamiliarity with statistical tools, risk analysis (FMEA), and CAPA systems\nExperience in lean manufacturing or continuous improvement environments\nStrong technical judgment and problem-solving skills\nAbility to lead supplier interactions and drive accountability\nExcellent communication and cross-functional collaboration skills\nStrong root cause analysis and data-driven decision-making capability\nAbility to manage multiple priorities in a fast-paced NPI and production environment\nHigh attention to detail and regulatory compliance mindset\nWillingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel\nPreferred CertificationsISO 13485 Internal Auditor certification preferred.\nASQ certifications (CQE, CQA, or similar) are a 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