Associate Quality Engineer

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

The Interventional Urology Operations Associate Quality Engineer is responsible for supporting and maintaining quality compliance within US Operations. In all actions, they will demonstrate a primary commitment to patient safety and product quality.

Major Areas of Accountability

• Provide Quality Engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues
• Quarantine and disposition non-conforming product
• Initiate and own non-conformances, including root cause analysis
• Participate in Material Review Board (MRB) meetings
• Participate in or lead Corrective and Preventive Actions as appropriate
• Assist in preparing, reviewing and approving quality documentation, including SOPs and work instructions
• Initiate and support Change Controls to update documentation and processes
• Support complaint investigations
• Identify and justify opportunities for quality and continuous improvement activities
• Perform data analysis, write summary reports and other technical memoranda
• Maintain applicable QMS instructions
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned.

Basic 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.

Required Knowledge, Skills and Abilities

• Ability to work independently and with general direction
• Excellent written & oral communication skills, strong technical writing skills
• Strong problems solving and trouble shooting skills
• Curious and eager to learn in a fast-paced, regulated industry
• Ability to effectively interact with various internal and external customers/ vendors
• Ability to convey a positive and professional image to internal and external customers
• Ability to multi-task and prioritize multiple projects
• Ability to communicate and train cross functionally at every level of the business
• Understanding of FDA, QSMR, ISO 13485 and ISO 14971 requirements.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well‑being, foster your professional growth, and ensure a healthy work‑life balance. Here is some of what you can expect:

• Health and Wellness : Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non‑birthing parents.
• Financial Security : A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance : Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development : Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards : Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture : A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team‑building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation : The compensation range for this position is $73,767 - $110,650 . Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark