Quality Engineer Associate | Impactful Medical Devices

Coloplast; Minneapolis (MN); On-site; USD 74,000 - 111,000; Full time

Benefits offered by this job

Health and Wellness

Financial Security (401(k) with match)

Work-Life Balance (PTO, flexible work)

Professional Development (tuition/reim

Job summary

Coloplast in Minneapolis seeks an Interventional Urology Operations Associate Quality Engineer to support and maintain quality compliance within US Operations, prioritizing patient safety and product quality. You will ensure FDA/ISO compliance and lead quality initiatives across QA activities.

Responsibilities include managing non-conformances, MRB participation, CAPA activities, change controls, and preparing quality documentation while collaborating with cross-functional teams to drive

Qualifications

• Bachelor’s degree in engineering or related field.
• 0-2+ years of related manufacturing or relevant work experience.
• Self-motivated and self-managed within a dynamic and collaborative team environment.
• Strong analytical and problem-solving skills.
• High performing individual that is able to accept challenges and opportunities as they arise.

Responsibilities

• Provide Quality Engineering support to US Operations to ensure FDA/ISO compliance.
• Quarantine and disposition non-conforming product.
• Initiate and own non-conformances, including root cause analysis.
• Participate in MRB meetings and CAPA activities.
• Assist in preparing, reviewing and approving quality documentation (SOPs/work instructions).
• Initiate and support Change Controls to update documentation and processes.
• Support complaint investigations and quality data analysis.
• Identify opportunities for quality and continuous improvement.

Skills

Analytical and problem-solving

Self-motivated

Independent work

Communication skills

Cross-functional collaboration

Fast learner

Education

Bachelor’s degree in engineering or related field

Job description

Coloplast in Minneapolis seeks an Interventional Urology Operations Associate Quality Engineer to support and maintain quality compliance within US Operations, prioritizing patient safety and product quality. You will ensure FDA/ISO compliance and lead quality initiatives across QA activities.

Responsibilities include managing non-conformances, MRB participation, CAPA activities, change controls, and preparing quality documentation while collaborating with cross-functional teams to drive