Supplier Quality Engineer
Merrimack ManufacturingManchester, NH
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Senior-level
Remote
Hybrid remote
Job Description
Company Overview:Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.Position SummaryThe Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.The SQE serves as a key interface between Engineering, Procurement, Quality, and the supplier base, supporting the assurance that suppliers consistently meet defined quality, regulatory, and performance expectations. This role supports supplier qualification activities for NPI programs, including onboarding of new suppliers, documentation review, and participation in process validation and design transfer activities. The SQE also supports sustaining supplier quality activities for production materials and services, including monitoring supplier performance and supporting resolution of supplier-related quality issues.Key ResponsibilitiesSupplier Qualification & NPI Support
- Support supplier qualification activities for New Product Introduction (NPI) projects
- Conduct supplier assessments in accordance with established risk-based procedures
- Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
- Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
- Review supplier documentation including certifications, quality records, and validation evidence
- Support supplier readiness activities for production launch, including process and quality system evaluations
- Participate in design transfer and process validation activities involving suppliers
- Support supplier quality oversight for assigned NPI projects and production suppliers
- Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
- Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
- Conduct supplier performance reviews and drive continuous improvement initiatives
- Support containment, root cause analysis, and resolution of supplier-related quality issues
- Perform risk-based supplier re-evaluations and periodic assessments
- Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
- Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
- Support external and internal audits involving supplier quality systems
- Ensure supplier quality agreements are established and maintained
- Drive adherence to change notification and supplier control requirements
- Partner with Design Authority (customer), Procurement, Manufacturing and Engineering
- Support material nonconformance investigations and disposition decisions
- Provide supplier risk input to project teams and change control processes
- Support supply continuity and risk mitigation strategies
- Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
- 1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
- Strong knowledge of ISO 13485 and medical device regulatory requirements
- Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
- Exposure to supplier quality, manufacturing, or inspection processes preferred
- Experience supporting NPI, manufacturing, or engineering projects a plus
- Good analytical and problem-solving skills
- Ability to work effectively in cross-functional teams
- Strong communication and documentation skills
- Ability interpret mechanical drawings (CAD files)
- Attention to detail and commitment to quality
- Ability to manage multiple tasks in a dynamic environment
- Basic understanding of manufacturing and quality systems concepts
- Familiarity with CAPA, nonconformance, or inspection processes is a plus
- Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 10-20% travel
- ISO 13485 Internal Auditor certification (or willingness to obtain).
- ASQ certifications (CQE, CQA, or similar) are a plus.
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FAQs About Supplier Quality Engineer Jobs at Merrimack Manufacturing
What is the work location for this position at Merrimack Manufacturing?
This job at Merrimack Manufacturing is located in Manchester, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Merrimack Manufacturing?
Employer has not shared pay details for this role.
What employment applies to this position at Merrimack Manufacturing?
Merrimack Manufacturing lists this role as a Full-time position.
What experience level is required for this role at Merrimack Manufacturing?
Merrimack Manufacturing is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What is the process to apply for this position at Merrimack Manufacturing?
You can apply for this role at Merrimack Manufacturing either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.