Supplier Quality Engineer / Senior Supplier Quality Engineer

Top Prospect Group; Manchester (NH); On-site; USD 65,000 - 115,000; Full time

Job summary

Top Prospect Group in Manchester, NH is seeking a Supplier Quality Engineer (SQE) or Senior SQE to strengthen supplier quality across NPI and manufacturing. You will partner with Engineering, Quality, and Procurement to ensure suppliers meet quality, regulatory, and performance expectations.

The role requires knowledge of ISO 13485 and FDA QSR, experience with supplier qualifications, audits, CAPA/SCAR, and risk management, plus travel up to 20% to support supplier activities.

Qualifications

• Bachelor’s Degree in Engineering (or related technical discipline).
• 1–3 years for Supplier Quality Engineer in regulated industries.
• 3–5+ years for Senior SQE in medical device or regulated manufacturing environments.

Responsibilities

• Support or lead supplier qualification activities for NPI projects.
• Conduct risk-based supplier assessments and evaluations.
• Participate in supplier audits (onsite and remote).
• Review supplier certifications, quality records, and validation documentation.
• Lead or support SCARs and CAPA investigations and closures.
• Monitor supplier performance through quality metrics and delivery performance.

Skills

ISO 13485

FDA 820

CAPA/SCAR

Risk mgmt

Education

Bachelor’s Degree in Engineering

Job description

Job Title: Supplier Quality Engineer / Senior Supplier Quality Engineer

Location: Manchester, NH

Type: Direct Hire

Salary: $65,000 – $115,000+ (Based on Experience)

Schedule: Monday–Friday, 7:00/8:00 AM – 4:00/5:00 PM

Travel: Approximately 10–20% Domestic & International

Openings: 3 Positions Available

Start Date: ASAP

POSITION OVERVIEW

We are actively seeking both Supplier Quality Engineers (SQE) and Senior Supplier Quality Engineers (Sr. SQE) to support supplier quality initiatives within a growing medical device manufacturing environment. These positions play a critical role in supporting both New Product Introduction (NPI) and sustaining manufacturing operations by ensuring supplier compliance, quality performance, and regulatory adherence throughout the supply chain. The ideal candidates will serve as key liaisons between Engineering, Procurement, Manufacturing, Quality, customers, and suppliers to ensure materials, components, and services consistently meet quality, regulatory, and performance expectations.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Support or lead supplier qualification activities for New Product Introduction (NPI) projects
• Conduct risk-based supplier assessments and evaluations
• Participate in supplier selection activities alongside Engineering, Procurement, and Quality teams
• Perform supplier audits (onsite and remote) for qualification and surveillance purposes
• Review supplier certifications, quality records, validation documentation, and compliance records
• Support supplier readiness activities for production launch, including process evaluations and quality system assessments
• Participate in design transfer activities and process validation efforts involving suppliers
• Evaluate supplier manufacturing capabilities, capacity, quality systems, and process controls
• Monitor supplier performance through quality metrics, delivery performance, defects, and SCAR activity
• Lead or support Supplier Corrective Action Requests (SCARs), CAPA investigations, and closure activities
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment activities, root cause investigations, and resolution of supplier-related quality issues
• Perform supplier re-evaluations and periodic risk-based assessments
• Maintain strong supplier relationships while driving accountability and quality performance
• Ensure supplier compliance with ISO 13485, FDA Quality System Regulations, and applicable quality requirements
• Maintain and improve Approved Supplier List (ASL) processes and supplier risk classifications
• Support internal audits, customer audits, and regulatory inspections involving supplier quality systems
• Ensure supplier quality agreements are established and maintained
• Support change notification management and supplier control processes
• Partner with Engineering, Manufacturing, Procurement, Quality Assurance, and customer design teams
• Support material nonconformance investigations and disposition decisions
• Provide supplier risk assessments and recommendations to project teams
• Participate in change control and risk mitigation activities
• Support supply continuity planning and supplier development initiatives

QUALIFICATIONS

• Bachelor’s Degree in Engineering, Life Sciences, or related technical discipline; equivalent experience may be considered
• Supplier Quality Engineer: 1–3 years of Supplier Quality, Quality Engineering, Manufacturing Quality, or related regulated industry experience
• Senior Supplier Quality Engineer: 3–5+ years of Supplier Quality or Quality Engineering experience within medical device or regulated manufacturing environments
• Strong knowledge of ISO 13485 and medical device quality systems
• Knowledge of FDA Quality System Regulations (21 CFR Part 820)
• Experience with supplier qualification, supplier audits, supplier development, and supplier performance management preferred
• Experience supporting New Product Introduction (NPI), design transfer, manufacturing, or engineering projects preferred
• Understanding of manufacturing processes, validation methodologies, and quality systems
• Familiarity with CAPA, SCAR, nonconformance investigations, and root cause analysis methodologies
• Experience with FMEA, risk management, and statistical quality tools preferred
• Ability to interpret engineering drawings and CAD documentation
• Experience within medical device manufacturing preferred
• Contract manufacturing and global supplier management experience is a plus
• Lean Manufacturing and Continuous Improvement experience preferred
• Strong communication, documentation, analytical, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Willingness to travel domestically and internationally as needed (10–20%)

PREFERRED CERTIFICATIONS

• ISO 13485 Internal Auditor Certification
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• Other relevant Quality or Regulatory certifications

COMPANY OVERVIEW

Top Prospect Group, now part of HW Staffing Solutions, specializes in connecting engineering, manufacturing, quality, and technical professionals with leading organizations throughout New England and across the United States. We partner with innovative companies in the medical device, aerospace, advanced manufacturing, and regulated industries to identify top talent for critical hiring needs.