DEKA Research & Development

1 month ago

Supplier Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

The Supplier Quality Engineer (SQE) ensures supplier quality across NPI and sustaining manufacturing in a regulated medical device environment. Acts as the liaison between Engineering, Procurement, and Quality to qualify, monitor, and improve suppliers, support audits, design transfers, and process validations, and drive containment and corrective actions to maintain compliance with ISO 13485 and 21 CFR Part 820.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Key Responsibilities

•Support supplier qualification activities for New Product Introduction (NPI) projects
•Conduct supplier assessments and supplier readiness for production launches
•Participate in supplier audits (remote and onsite) as part of qualification and surveillance
•Review supplier documentation including certifications, quality records, and validation evidence
•Support containment, root cause analysis, and resolution of supplier-related quality issues

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
•1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
•Strong knowledge of ISO 13485 and medical device regulatory requirements (21 CFR Part 820)
•Understanding of quality systems and regulatory expectations (ISO 13485)
•Experience supporting NPI, manufacturing, or engineering projects is a plus

Experience:1-3 yearsMedical deviceRegulated industrySupplier quality

Education:Bachelor's

Skills:AnalyticalProblem-solvingCross-functional teamwork

Tech Stack:ISO 1348521 CFR Part 820Quality systemsRegulatory compliance

Company Brief

DEKA Research & Development

DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor

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DEKA Research & Development

1 month ago

Supplier Quality Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Key Responsibilities

•Support supplier qualification activities for New Product Introduction (NPI) projects
•Conduct supplier assessments and supplier readiness for production launches
•Participate in supplier audits (remote and onsite) as part of qualification and surveillance
•Review supplier documentation including certifications, quality records, and validation evidence
•Support containment, root cause analysis, and resolution of supplier-related quality issues

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience)
•1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
•Strong knowledge of ISO 13485 and medical device regulatory requirements (21 CFR Part 820)
•Understanding of quality systems and regulatory expectations (ISO 13485)
•Experience supporting NPI, manufacturing, or engineering projects is a plus

Experience:1-3 yearsMedical deviceRegulated industrySupplier quality

Education:Bachelor's

Skills:AnalyticalProblem-solvingCross-functional teamwork

Tech Stack:ISO 1348521 CFR Part 820Quality systemsRegulatory compliance

Company Brief

DEKA Research & Development

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor