MedTech Supplier Quality Engineer: Design Transfer

DEKA Research and Development; Manchester (NH); On-site; USD 85,000 - 125,000; Full time

Job summary

DEKA Research and Development is seeking a Supplier Quality Engineer to lead supplier quality activities during design transfer and validation. You will ensure supplier compliance to 21 CFR, ISO 13485, and drive supplier development and performance management with design teams and manufacturing partners.

The role emphasizes process/tool validation support, sustaining supplier quality for production materials, and collaborating across procurement, engineering, and contract manufacturing.

Qualifications

• Bachelor's degree or equivalent in a technical field with regulated industry exposure.
• 3–5 years in Supplier Quality/Quality Engineering in medical device or regulated setting.
• Strong knowledge of ISO 13485 and medical device regulatory requirements.
• Experience with supplier audits, qualification, and risk-based supplier management.
• Experience supporting NPI/design transfer activities preferred.
• Solid understanding of manufacturing processes, validation and quality systems.

Responsibilities

• Lead supplier quality activities during design transfer and process/product validation.
• Review and approve supplier documentation (certifications, validations, quality records).
• Ensure supplier readiness for production launches with quality systems and controls.
• Support IQ/OQ/PQ, MSA, and statistical analysis during validation.
• Manage supplier performance via quality metrics and CAPA/SCAR processes.
• Conduct supplier performance reviews and drive continuous improvement.
• Coordinate with Contract Manufacturing, Procurement, and Engineering.
• Assist in containment and root-cause analysis of supplier-related issues.

Skills

NPI/design transfer experience

ISO 13485 knowledge

Supplier audits

CAPA/SCAR management

Process/tool validation

Troubleshooting/problem solving

Cross-functional collaboration

Regulatory compliance mindset

Travel willingness

Education

Bachelor's degree in Engineering/Life Sciences or related

Equivalent regulated industry experience

Tools

Minitab

Job description

DEKA Research and Development is seeking a Supplier Quality Engineer to lead supplier quality activities during design transfer and validation. You will ensure supplier compliance to 21 CFR, ISO 13485, and drive supplier development and performance management with design teams and manufacturing partners.

The role emphasizes process/tool validation support, sustaining supplier quality for production materials, and collaborating across procurement, engineering, and contract manufacturing.