Supplier Quality Engineer - Design Transfer & Compliance

deka

Richmond (NH)

On-site

USD 85,000 - 120,000

Full time

14 days+

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Benefits offered by this job

Travel up to 20%

Job summary

DEKA is seeking a Supplier Quality Engineer responsible for leading supplier quality activities during design transfer and validation, ensuring ISO 13485 compliance and robust supplier development with manufacturing partners.

You will collaborate across engineering, procurement, and contract manufacturing, review supplier docs, support QC strategies, and drive CAPA and SCAR closures while traveling up to 20% to supplier sites.

Qualifications

Bachelor's degree in Engineering or related field; regulated industry experience considered in lieu of degree.
3–5 years of experience in Supplier Quality or quality engineering in medical device or regulated industry.
Strong knowledge of ISO 13485 and medical device regulatory requirements.

Responsibilities

Review and approve supplier documentation including certifications, validations, and quality records.
Ensure supplier readiness for production launch, including quality systems and process controls.
Participate in design transfer and process/tool validation activities (IQ/OQ/PQ, MSA, and statistical analysis).
Lead supplier development and continuous improvement to ensure effective design transfer.
Monitor supplier performance using quality metrics and drive corrective actions (SCAR/CAPA).