Supplier Quality Engineer – Audits & CAPA in Regulated Med Devices

Scorpion Therapeutics; Harvard (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Regulated manufacturing

Supplier qualification

CAPA

Audit leadership

Biotech/pharma focus

Job summary

Scorpion Therapeutics seeks a Supplier Quality Engineer to ensure quality, reliability, and regulatory compliance of materials in manufacturing and supply chain in a regulated environment.

Responsibilities include supplier qualification, performance management, and leading audits per ISO 13485, ISO 9001, and FDA standards. The role emphasizes CAPA, process improvements, and strong analytical skills in a biotech setting.

Qualifications

• Bachelor's in Engineering or related field.
• 2–5 years in Supplier Quality or Quality Engineering, ideally in Medical Device, IVD, biotech, or pharma manufacturing.
• ASQ CQE, CSQP, Six Sigma Green Belt preferred; auditor experience plus knowledge of PPAP, FMEA, SPC, cGMP, ISO 13485, FDA standards.

Responsibilities

• Qualify and onboard suppliers.
• Manage supplier performance.
• Conduct audits (ISO 13485, ISO 9001, FDA).
• Lead corrective actions.
• Support CAPA.
• Investigate nonconformities.
• Collaborate on process improvements.

Skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor's in Engineering or related field

Tools

PPAP

FMEA

SPC

Job description

Scorpion Therapeutics seeks a Supplier Quality Engineer to ensure quality, reliability, and regulatory compliance of materials in manufacturing and supply chain in a regulated environment.

Responsibilities include supplier qualification, performance management, and leading audits per ISO 13485, ISO 9001, and FDA standards. The role emphasizes CAPA, process improvements, and strong analytical skills in a biotech setting.