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

Our On-Demand Talent Solutions team is excited to announce that we are hiring a Senior Supplier Quality Engineer of Plastics on behalf of our valued client. This client has improved the lives of patients who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

The Senior Supplier Quality Engineer – Plastics will be responsible for supporting Plastics and Silicone Supplier Quality function while providing both technical ownership across a global supplier network. For supplier quality governance, supplier performance management, quality systems oversight, and execution of strategic initiatives supporting new product introduction, manufacturing expansion, supply continuity, and regulatory compliance.

Responsibilities

• Own supplier quality deliverables supporting Plastics category sourcing strategies, supplier governance, business growth, manufacturing expansion, dual sourcing, and continuity of production.
• Demonstrate strong technical expertise in Plastics manufacturing processes and supplier quality systems, including injection molding, tooling and mold design, polymer materials, resin handling and drying, automated assembly operations, process validation, dimensional and functional inspection, SPC, and product reliability testing.
• Lead supplier selection, qualification, and development activities and drive continuous improvement through supplier scorecards, performance reviews, quality improvement plans, and corrective action programs.
• Monitor supplier performance and drive measurable improvements in quality, responsiveness, delivery performance, and process capability, while proactively identifying and mitigating product, supplier, operational, and compliance risks.
• Lead supplier quality system assessments, process audits, surveillance audits, and for-cause investigations, ensuring compliance with corporate quality systems, medical device regulations, industry standards, and supplier quality requirements.
• Review and approve supplier qualification documentation, process validations, quality plans, inspection strategies, change notifications, and supplier change requests.
• Lead root cause investigations and Supplier Corrective Action Requests (SCARs), containment activities, effectiveness monitoring, and sustainable corrective actions; serve as escalation point for critical supplier quality issues and compliance risks.
• Partner with Engineering, Operations, Procurement, Supply Chain Management, Supplier Development, and suppliers to improve process capability and manufacturing performance and support new product introductions, supplier transfers, capacity expansion, and manufacturing readiness initiatives.

Qualifications

• Bachelor’s degree in Plastics Engineering, Mechanical Engineering, Biomedical Engineering, or related technical discipline; 5–8 years of progressive experience with a bachelor’s degree or 3 years with a master’s degree in medical device Supplier Quality Engineering, Quality Engineering, or Manufacturing Engineering.
• At least 2 years of demonstrated technical, project, team leadership, or people management experience, including supplier performance improvement initiatives and cross-functional quality programs; strong communication and project management capabilities.
• Comprehensive understanding of plastics manufacturing technologies, including injection molding, extrusion, polymer component production, tooling and mold maintenance, automated assembly operations, secondary manufacturing processes, and plastic component suppliers.
• Strong understanding of Quality Management Systems (QMS), supplier quality systems, supplier qualification, audits, risk management, and regulatory frameworks, including 21 CFR Part 820, 21 CFR Part 11, and IPC-A-610 standards.
• Expertise in PPAP, DOE, Process Capability Analysis, Gage R&R, Control Plans, SPC, Failure Analysis, Inspection Methodologies, problem-solving methodologies, and continuous improvement techniques.
• Experience working within regulated industries such as medical devices, pharmaceuticals, aerospace, or other highly regulated manufacturing environments; global supplier quality experience and ASQ CQE, CQA, Six Sigma Green Belt/Black Belt, or equivalent certification preferred.