DEKA Research & Development

1 month ago

Senior Supplier Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Senior Supplier Quality Engineer leading supplier quality activities for NPI and sustaining manufacturing, ensuring ISO 13485/regulatory compliance, conducting supplier qualifications, audits, and CAPA-driven improvements to deliver ready-for-production supplier performance.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Sr. Manager level

Key Responsibilities

•Lead supplier qualification activities for New Product Introductions (NPI) and support sustaining supplier quality for production materials
•Conduct risk-based supplier assessments aligned with product and process criticality and participate in supplier audits (remote and onsite)
•Review and approve supplier documentation including certifications, validations, and quality records; drive containment and remediation (SCAR/CAPA) activities
•Ensure supplier readiness for production launches including capacity, quality systems, and process controls; support design transfer and process validation with supplier input
•Monitor supplier performance using quality metrics and drive continuous improvement through supplier reviews and cross-functional collaboration

Travel: Low travel

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry
•3–5 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
•Experience with supplier audits, qualification, and risk-based supplier management
•Experience supporting NPI or design transfer activities strongly preferred

Experience:3-5 yearsMedical devicesRegulated industrySupplier qualityQuality engineering

Education:Bachelor's

Skills:Problem-solvingCommunicationCross-functional collaborationRoot cause analysisData-driven decision-making

Certifications:ISO 13485 Internal Auditor (preferred)

Languages:English

Tech Stack:CADFMEACAPAStatistical toolsLeanProcess validation

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

Senior Supplier Quality Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Sr. Manager level

Key Responsibilities

•Lead supplier qualification activities for New Product Introductions (NPI) and support sustaining supplier quality for production materials
•Conduct risk-based supplier assessments aligned with product and process criticality and participate in supplier audits (remote and onsite)
•Review and approve supplier documentation including certifications, validations, and quality records; drive containment and remediation (SCAR/CAPA) activities
•Ensure supplier readiness for production launches including capacity, quality systems, and process controls; support design transfer and process validation with supplier input
•Monitor supplier performance using quality metrics and drive continuous improvement through supplier reviews and cross-functional collaboration

Travel: Low travel

Key Requirements

•Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry
•3–5 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
•Experience with supplier audits, qualification, and risk-based supplier management
•Experience supporting NPI or design transfer activities strongly preferred

Experience:3-5 yearsMedical devicesRegulated industrySupplier qualityQuality engineering

Education:Bachelor's

Skills:Problem-solvingCommunicationCross-functional collaborationRoot cause analysisData-driven decision-making

Certifications:ISO 13485 Internal Auditor (preferred)

Languages:English

Tech Stack:CADFMEACAPAStatistical toolsLeanProcess validation

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