Senior Plastics Supplier Quality Engineer

Stevenson Search Partners; Massachusetts; On-site; USD 110,000 - 160,000; Full time

Job summary

Stevenson Search Partners is seeking a Senior Supplier Quality Engineer - Plastics for a medical device client in the United States. You will own supplier quality deliverables, lead plastics supplier evaluation, and drive CAPA and continuous improvement across a global network.

You will apply expertise in injection molding, tooling, and polymer materials, ensuring QMS compliance with 21 CFR Part 820/11 and IPC-A-610.

Qualifications

• Bachelor’s degree in Plastics Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline; 5–8 years in medical device SQE/QA/Manufacturing Engineering.
• At least 2 years of demonstrated technical, project, team leadership, or people management experience.
• Comprehensive understanding of plastics manufacturing technologies: injection molding, extrusion, tooling, polymer components.
• Strong knowledge of QMS, supplier qualification, audits, risk management, and regulatory frameworks (21 CFR Part 820, Part 11, IPC-A-610).
• Expertise in PPAP, DOE, Process Capability Analysis, Gage R&R, SPC, RCA, and continuous improvement methods.
• Experience in regulated industries with global supplier quality exposure; ASQ CQE/CQA or Six Sigma certification preferred.

Responsibilities

• Own supplier quality deliverables supporting plastics category sourcing strategies and supplier governance.
• Demonstrate strong technical expertise in plastics processes and supplier quality systems.
• Lead supplier selection, qualification, and development activities; drive continuous improvement via scorecards and CAPA.
• Monitor supplier performance; drive improvements in quality, delivery, and process capability; mitigate risks.
• Lead supplier quality system assessments, audits, and for-cause investigations to ensure regulatory compliance.
• Review and approve qualification docs, process validations, quality plans, and change requests.

Skills

Leadership

Project management

Communication

Supplier quality knowledge

Education

Bachelor's degree in Plastics/Mechanical/Bio engineering

Master's degree (preferred)

Job description

Stevenson Search Partners is seeking a Senior Supplier Quality Engineer - Plastics for a medical device client in the United States. You will own supplier quality deliverables, lead plastics supplier evaluation, and drive CAPA and continuous improvement across a global network.

You will apply expertise in injection molding, tooling, and polymer materials, ensuring QMS compliance with 21 CFR Part 820/11 and IPC-A-610.