Supplier Quality Engineer II

Scorpion Therapeutics; Mansfield (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Scorpion Therapeutics is seeking a Supplier Quality Engineer II to support contract manufacturers and raw material suppliers in the production of medical devices. The role emphasizes GMP/ISO-aligned quality systems, supplier audits, CAPA, and cross-functional collaboration.

You will monitor supplier performance, oversee change controls and quality agreements, and partner with QC, manufacturing, and purchasing to drive continuous improvement and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• At least 3 years in GMP/ISO-regulated industry.
• Knowledge of medical device standards such as ISO 13485, 21 CFR Part 820.
• Strong communication, analytical, and problem-solving skills.
• Proficient with ERP, PLM, Microsoft Office, and statistical techniques.

Responsibilities

• Conduct supplier audits per GMP and ISO standards.
• Monitor supplier performance and CAPA/nonconformances.
• Manage supplier change control and quality agreements.
• Collaborate with QC, manufacturing, and purchasing to drive continuous improvement and compliance.

Skills

Communication skills

Analytical thinking

Problem solving

Education

Bachelor's degree

Tools

ERP systems

PLM

MS Office

Statistics

Job description

Role: Supplier Quality Engineer II supporting contract manufacturers and raw material suppliers in the production of medical devices.

Responsibilities

• Conduct supplier audits per GMP and ISO standards,
• Monitor supplier performance,
• Manage CAPA and nonconformances,
• Oversee supplier change control and quality agreements,
• Collaborate with QC, manufacturing, and purchasing to drive continuous improvement and compliance

Requirements

• Bachelor’s in Engineering, Life Sciences, or related field;
• At least 3 years in GMP/ISO-regulated industry;
• Knowledge of medical device standards such as ISO 13485, 21 CFR Part 820;
• Strong communication, analytical, and problem-solving skills;
• Proficient with ERP, PLM, Microsoft Office, and statistical techniques;

Preferred

• Experience in medical device manufacturing, process validation (IQ, OQ, PQ), and auditor certification to ISO 13485:2016;
• Familiarity with machining, injection molding, or electro-mechanical components

High Value: focus on supplier qualification, validation, and regulatory compliance within a regulated medical device environment.

WorkSetup: not specified; role emphasizes cross-functional partner collaboration and compliance oversight.