Supplier Quality Engineer

SEC Group; Eden Prairie (MN); On-site; USD 95,000 - 135,000; Full time

Job summary

SEC Group's medical device client in Eden Prairie, MN is seeking an experienced Senior Supplier Quality Engineer to join its Quality organization. This role focuses on maintaining and improving supplier quality, product quality, and QMS performance in a regulated environment.

You will lead supplier quality activities, CAPA investigations, supplier audits, and statistical analysis, partnering with Engineering, Operations and external suppliers.

Qualifications

• Bachelor’s Degree in Engineering.
• Minimum of 5 years of related experience in Supplier Quality Engineering.
• Experience in ISO 13485 and FDA QMS requirements.
• Experience with CAPA, supplier audits, SPC, and continuous improvement.

Responsibilities

• Lead supplier quality activities, including audits and supplier qualification.
• Lead CAPA investigations, root-cause analysis, and corrective actions.
• Develop sampling plans, SPC, DOE, and trend analysis.
• Collaborate with Engineering, Operations, suppliers, and QA teams.
• Dispostion nonconforming materials and ensure product integrity.

Skills

CAPA

Root cause analysis

Statistical methods

Process improvement

Cross-functional collaboration

Education

Bachelor's Degree in Engineering

Tools

TrackWise

Windchill PLM

Grand Avenue

Job description

Our medical device client in the Eden Prairie, MN area is seeking an experienced Senior Supplier Quality Engineer to join its Quality organization. This individual will play a key role in maintaining and improving supplier quality, product quality, and Quality Management System (QMS) performance within a highly regulated medical device environment.

The Senior Supplier Quality Engineer will lead supplier quality engineering activities, Supplier Audits, CAPA investigations, corrective actions, quality system improvements, and statistical process analysis, while partnering cross-functionally with Engineering, Operations, Quality, and external suppliers. The ideal candidate will have strong experience with ISO 13485, FDA quality requirements, supplier controls, CAPA, SPC, and continuous improvement.

This is an onsite position in the Eden Prairie area with up to 10% travel to supplier locations.

Responsibilities:

• Lead Supplier Quality activities, including Supplier Audits, supplier qualification, corrective actions, supplier monitoring, and supplier quality improvement initiatives.
• Lead CAPA investigations, root cause analysis, problem-solving activities, and product/process corrective actions.
• Develop and implement statistically valid sampling plans, process capability studies, Statistical Process Control (SPC), trend analysis, and Designed Experiments (DOE).
• Serve as a Quality Core Team member on cross-functional new product and service development teams.
• Evaluate and improve Quality Management System (QMS) processes to strengthen product, supplier, and quality system performance.
• Lead projects focused on quality systems, supplier quality, product quality, service quality, and continuous improvement.
• Develop analyses, metrics, and reports to measure QMS and supplier quality performance.
• Lead and support internal and external quality system audits and Supplier Audits, ensuring compliance with applicable ISO 13485 and FDA requirements.
• Evaluate and disposition nonconforming materials and processes while maintaining product integrity and compliance.
• Collaborate with Engineering, Operations, suppliers, and other Quality teams to resolve quality issues and implement effective corrective actions.
• Provide technical guidance and support to Quality Engineers and other quality personnel.

Requirements:

• Bachelor’s Degree in Engineering.
• Minimum of 5 years of related experience in Supplier Quality Engineering, Quality Engineering, Manufacturing Engineering, and/or Quality Systems.
• 5+ years of experience working within an ISO-certified Quality Management System (QMS) environment.
• Experience within the medical device industry or another highly regulated manufacturing environment.
• Strong knowledge of ISO 13485 requirements and quality system principles.
• Hands-on experience with supplier controls, Supplier Audits, supplier qualification, supplier monitoring, and supplier corrective actions.
• Familiarity with FDA Quality Management System Regulation (QMSR) and/or GMP requirements.
• Strong knowledge of CAPA, root cause analysis, corrective actions, SPC, statistical analysis, process capability, and continuous improvement methodologies.
• Experience with quality systems such as TrackWise, Windchill PLM, Grand Avenue, or similar platforms preferred.
• ASQ certification preferred.
• Ability to travel to local supplier locations up to 10%.