Quality Engineer - Medical Devices, CAPA & QMS Champion

Imagine; Shakopee (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

Imagine in Minnesota seeks a Quality Engineer to drive preventative quality measures for medical device customers and support QA functions across the organization. You will address customer quality complaints, ensure ISO 9001 compliance, and contribute to a total quality manufacturing environment.

You will lead SCARs and CAPA activities, maintain the QMS, and collaborate with customers and internal teams. Strong analytical and communication skills, plus experience in manufacturing quality, are

Qualifications

• Experience in supplier and/or customer quality in manufacturing.
• Experience with ISO 9001, Root Cause Analysis, SCARs and CAPAs.
• Bilingual or multilingual proficiency preferred (ASL included).

Responsibilities

• Lead timely completion of SCARs and CAPA activities with medical device customers.
• Collaborate with internal teams to own corrective actions (training, SOP updates, audits).
• Prepare and present reports and compliance documentation to medical customers.
• Maintain documentation for regulatory submissions and inspections.
• Ensure products meet FDA, ISO and other quality standards.
• Develop and maintain QMS to ISO 9001:2015 and company objectives.
• Provide guidance and training on medical quality standards to staff.
• Design inspection/testing plans; perform QA tests and data analysis.
• Lead cross-functional teams for root-cause analyses and CAPA closure.
• Support audits and customer quality visits.

Skills

Detail oriented

Communication skills

Analytical thinking

Root Cause Analysis

Six Sigma

MS Office

ISO 9001

Tools

Control charts

ANOVA charts

Sample size

Job description

Imagine in Minnesota seeks a Quality Engineer to drive preventative quality measures for medical device customers and support QA functions across the organization. You will address customer quality complaints, ensure ISO 9001 compliance, and contribute to a total quality manufacturing environment.

You will lead SCARs and CAPA activities, maintain the QMS, and collaborate with customers and internal teams. Strong analytical and communication skills, plus experience in manufacturing quality, are