{"id":1695198,"url":"https://alion.io/job/deka-research-development-supplier-quality-engineer-deka-research-development","title":"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":"middle","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":68000,"max_usd":126000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2884},"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":"2026-10-07T21:21:07Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"The Supplier Quality Engineer is responsible for leading supplier quality activities during design transfer and process/product validation. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives supplier development and performance management processes. The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support process and tool validation support, while also managing sustaining supplier quality performance for production materials and services.\nHow you will make an impact as a Supplier Quality Engineer:\nReview and approve supplier documentation including certifications, validations, and quality records\nEnsure supplier readiness for production launch, including quality systems, and process controls\nParticipate in design transfer and process/tool validation activities such as IQ/OQ/PQ, MSA and Statistical analysis\nSustaining Supplier Quality ManagementSupplier development and continuous improvement to ensure effective design transfer\nMonitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)\nLead/Support 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\nSupplier Quality System & ComplianceEnsure supplier compliance with applicable regulatory and quality system requirements including ISO 13485\nSupport external and internal audits involving supplier quality systems\nDrive adherence to change notification and supplier control requirements\nCross-Functional CollaborationPartner with Contract Manufacturing, Procurement, 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\nWriting Test Methods to support Validation\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 medical device manufacturing and global supply chains\nAbility to interpret mechanical drawings\nFamiliarity with statistical tools (Minitab), risk analysis (FMEA), and CAPA systems\nExperience in process and tool validation\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 (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.","description_format":"text","description_chars":3792,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T12:01:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 12 · green card filings: 1","filings_12m":12,"filings_prev_12m":14,"green_card_filings_12m":1,"median_offered_wage_usd":110962,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.895,"p_room":1,"age_days":4,"expected_fill_days":34,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-10-07T05:47:15Z"},"pay":null,"html_url":"https://alion.io/job/deka-research-development-supplier-quality-engineer-deka-research-development","json_url":"https://alion.io/job/deka-research-development-supplier-quality-engineer-deka-research-development.json","meta":{"generated_at":"2026-10-08T00:24:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per 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