Supplier Quality Engineer

Techneeds; Manchester (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

Techneeds LLC is seeking a Supplier Quality Engineer in New Hampshire to support supplier quality activities within a regulated medical device environment.

You will help qualify new suppliers, participate in audits, review supplier documentation, and monitor performance to drive continuous improvement while collaborating with Engineering, Procurement, and Quality teams.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent experience in a regulated industry.
• Strong knowledge of ISO 13485 and regulatory requirements such as 21 CFR Part 820.
• Exposure to supplier quality, manufacturing, or inspection processes with CAPA/nonconformance familiarity.
• Analytical, problem-solving and cross-functional collaboration skills.
• Good communication and documentation skills; ability to interpret CAD drawings.
• Willingness to travel up to 20% domestically and internationally.
• Preferred ISO 13485 Internal Auditor or ASQ CQE/CQA certifications.

Responsibilities

• Participate in supplier audits to assess compliance and quality systems.
• Review supplier documentation and approve quality records.
• Support process validation activities for new and existing suppliers.
• Manage supplier-related quality issues to assure manufacturing quality.

Skills

ISO 13485 knowledge

CAPA experience

Cross-functional teamwork

Documentation skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Our client is looking for a Supplier Quality Engineer. This role plays a crucial part in supporting supplier quality activities within a fast-growing, regulated medical device environment. As a Supplier Quality Engineer, you will be responsible for ensuring supplier compliance with industry standards such as ISO 13485 and 21 CFR Part 820, supporting new product introductions, conducting supplier assessments, and monitoring supplier performance to drive continuous improvement. You will serve as a key interface between Engineering, Procurement, and Quality teams, helping to qualify new suppliers and maintain the quality of existing ones. Your day-to-day tasks will include participating in supplier audits, reviewing supplier documentation, supporting process validation, and managing supplier-related quality issues to ensure manufacturing quality and regulatory compliance. This position offers a blend of supplier qualification, quality oversight, and cross-functional collaboration in an innovative medical device company recognized for excellence in quality.

Work Schedule

Monday – Friday, 7:00 AM – 4:00 PM

Required Skills, Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent experience in a regulated industry 1-3 years of experience in Supplier Quality, Quality Engineering, or a related role within the medical device or regulated industry
• Strong knowledge of ISO 13485 and regulatory requirements such as 21 CFR Part 820
• Exposure to supplier quality, manufacturing, or inspection processes, with familiarity in CAPA, nonconformance, or inspection procedures preferred
• Excellent analytical, problem-solving, and cross-functional team collaboration skills
• Good communication and documentation skills, with the ability to interpret mechanical drawings (CAD files) and attention to detail
• Willingness to travel domestically and internationally up to 20% as needed
• Preferred certifications include ISO 13485 Internal Auditor or ASQ certifications like CQE or CQA