Senior Supplier Quality Engineer - Medical Devices (Onsite)

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

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.