Coloplast Corp

Quality Engineer

Coloplast Corp • $88K — $132K *
Minneapolis, MN 55407In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in science or engineering discipline.
  • 2+ years of experience in medical device manufacturing.
  • ASQ Certified Quality Engineer preferred.
  • Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971).
  • Experience with process validation and change control systems.

Responsibilities

  • Support US Operations with quality engineering to ensure compliance and address quality issues.
  • Recommend and implement process improvements for regulatory compliance.
  • Collaborate with new product development teams for manufacturing transitions.
  • Conduct root cause investigations for non-conformities.
  • Facilitate Material Review Board meetings and lead corrective actions.
  • Review and author validation documents, ensuring documentation up-to-date.
  • Perform data analysis and summarize in technical reports.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • Paid parental leave for birthing and non-birthing parents.
  • 401(k) plan with immediate company match and financial planning services.
  • Flexible work hours and generous paid time off.
  • Opportunities for professional development through training and mentorship.
  • Recognition programs for employee achievements and contributions.
Full Job Description
The Interventional Urology Operations Quality Engineer is responsible for supporting and maintaining quality compliance and will recommend and implement process improvements 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.
  • Recommend and implement quality improvements and processes to ensure regulatory compliance and promote continuous improvement.
  • Work with new product development teams to transfer new products into manufacturing.
  • Conduct and document root cause investigations of non-conforming processes and products.
  • Facilitate Material Review Board meetings.
  • Participate in or lead Corrective and Preventive Actions as appropriate.
  • Review sampling techniques/methods/rationale and test methods to ensure appropriateness.
  • Review quality content in change control for products and processes.
  • Review and author validation documents and validate processes.
  • Initiate Change Requests to update documentation and processes.
  • Perform data analysis; write summary reports and other technical memoranda.
  • Coordinate and support calibration activities - including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed.
  • Maintain applicable QMS instructions
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
  • Other duties as assigned


Basic Qualifications
  • Bachelor's degree in a relevant science or engineering discipline.
  • 2+ years related experience in medical device manufacturing.
  • ASQ Certified Quality Engineer preferred


Required Knowledge, Skills and Abilities
  • Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
  • Experience with process validation, change control systems, sample size determination, FMEA, and Gage R&R.
  • Ability to effectively manage multiple projects and priorities.
  • Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the operations quality function.
  • Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
  • Experience in performing internal audits.
  • Personifies and fosters the Coloplast Mission, Vision and Values.


  • Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
  • Ability to apply standard techniques, procedures, and criteria to perform assigned tasks.
  • Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the operations quality function.
  • Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
  • Preferred experience with Medical Device Systems with Software and Electrical Components
  • Experience performing internal audits.
  • Personifies and fosters the Coloplast Mission, Vision and Values.

    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 $88,372 - $132,558. 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.


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About Coloplast Corp

Coloplast Corp is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care. The company was founded in 1957 and is headquartered in Humlebaek, Denmark. Coloplast operates globally with production facilities in Denmark, Hungary, China, and the United States. The company's products are sold in more than 140 countries. Coloplast is committed to improving the quality of life for people who have intimate healthcare needs. The company's mission is to make life easier for people with intimate healthcare needs by developing products and services that make a difference to their lives.
Learn more about Coloplast Corp
Size
12,000 employees
Industry
Healthcare
Founded
1978
* Ladders Estimates

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