Sr Supplier Quality Engineer

Intepros; Billerica (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

Intepros is seeking a Sr. Supplier Quality Engineer to lead supplier quality activities, qualification of components and devices, and ongoing continuous improvement in a medical device manufacturing environment.

The role partners with engineering and operations to ensure GMP and regulatory compliance and to drive product quality. You will manage supplier audits, ASL processes, CAPA/NCMR, and change requests, mentor teams, and communicate risk and performance to leadership.

Qualifications

• 3–6 years of relevant experience.
• Medical device industry experience required.
• Electrical or Mechanical Engineering background preferred.
• Experience with component/product qualification.
• Strong knowledge of test method validation, equipment/process validation, and process capability.
• Experience with supplier quality, NCMRs, CAPA, audits, and quality systems.
• Ability to work independently and lead cross-functional projects.

Responsibilities

• Lead Supplier Quality activities and supplier qualification.
• Support product/component qualification, including test method, equipment, and process validations.
• Develop product acceptance strategies, receiving inspection requirements, and test methods.
• Lead Supplier Change Requests and supplier-related NCMRs/CAPA.
• Monitor supplier performance and resolve quality issues throughout the product lifecycle.
• Support Approved Supplier List (ASL) activities and supplier audits.
• Partner with Engineering, Quality, Operations, and suppliers to drive product quality and continuous improvement.
• Provide technical guidance related to GMP, regulatory, and quality requirements.
• Communicate supplier quality status, risks, and performance to leadership.

Skills

Supplier quality

CAPA

NCMR

Audits

Cross-functional leadership

Independent work

Education

Bachelor’s degree in Engineering

Job description

We’re seeking a Sr. Supplier Quality Engineer to support supplier quality, product qualification, and continuous improvement activities within a medical device manufacturing environment.

Responsibilities

• Lead Supplier Quality activities and supplier qualification.
• Support product/component qualification, including test method, equipment, and process validations.
• Develop product acceptance strategies, receiving inspection requirements, and test methods.
• Lead Supplier Change Requests and supplier-related NCMRs/CAPA.
• Monitor supplier performance and resolve quality issues throughout the product lifecycle.
• Support Approved Supplier List (ASL) activities and supplier audits.
• Partner with Engineering, Quality, Operations, and suppliers to drive product quality and continuous improvement.
• Provide technical guidance related to GMP, regulatory, and quality requirements.
• Communicate supplier quality status, risks, and performance to leadership.

Required Experience

• 3–6 years of relevant experience
• Medical device industry experience required
• Bachelor’s degree in Engineering
• Electrical or Mechanical Engineering background preferred
• Experience with component/product qualification
• Strong knowledge of test method validation, equipment/process validation, and process capability
• Experience with supplier quality, NCMRs, CAPA, audits, and quality systems
• Ability to work independently and lead cross-functional projects