Supplier Quality Engineer

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

Role

Supplier Quality Engineer responsible for ensuring quality, reliability, and regulatory compliance of materials in manufacturing and supply chain operations within a regulated environment.

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

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
• strong analytical, problem-solving, communication skills
• ASQ CQE, CSQP, Six Sigma Green Belt preferred
• auditor experience plus knowledge of PPAP, FMEA, SPC, cGMP, ISO 13485, FDA standards

High-Value

• regulated manufacturing
• supplier qualification
• CAPA
• audit leadership
• biotech/pharma focus

Work setup

onsite in a laboratory/production environment; physical ability to handle materials and perform extensive computer work; standard hours with occasional variation.