Senior Supplier Quality Engineer - Medical Devices & NPI

Merrimack Manufacturing; Manchester (NH); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Merrimack Manufacturing in Manchester, NH is seeking a Senior Supplier Quality Engineer to lead supplier quality across NPI and sustaining operations. You will ensure supplier capability to meet quality, regulatory, and performance expectations, partnering with design, engineering, procurement and QA.

Responsibilities include leading supplier qualification, conducting audits, monitoring performance with metrics, driving CAPA and risk-based improvements, and ensuring ISO 13485 compliance across

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 3–5 years of experience in Supplier Quality in medical devices or regulated industry.
• Strong knowledge of ISO 13485 and medical device regulatory requirements.
• Experience with supplier audits, qualification, and risk-based supplier management.
• Experience supporting NPI or design transfer activities strongly preferred.
• Strong understanding of manufacturing processes, validation, and quality systems.

Responsabilités

• Lead supplier qualification activities for NPI projects.
• Conduct supplier audits (remote and onsite) and review approvals of certifications, validations and quality records.
• Monitor supplier performance using quality metrics (SCARs, defects, delivery).
• Lead supplier corrective action (SCAR/CAPA) and ensure timely closure.
• Support containment, root cause analysis and resolution of supplier-related quality issues.
• Perform risk-based supplier re-evaluations and periodic assessments.

Connaissances

Supplier quality

ISO 13485

Audits

NPI support

Risk management

Cross-functional

Global supply

Formation

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Outils

CAD

CAPA systems

Description du poste

Merrimack Manufacturing in Manchester, NH is seeking a Senior Supplier Quality Engineer to lead supplier quality across NPI and sustaining operations. You will ensure supplier capability to meet quality, regulatory, and performance expectations, partnering with design, engineering, procurement and QA.

Responsibilities include leading supplier qualification, conducting audits, monitoring performance with metrics, driving CAPA and risk-based improvements, and ensuring ISO 13485 compliance across