Coloplast Corp

Associate Quality Engineer

Coloplast Corp • $73K — $110K *
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 engineering or related field
  • 0-2+ years of relevant experience in manufacturing
  • Strong analytical and problem-solving abilities
  • Excellent written and oral communication skills
  • Ability to work independently and in teams

Responsibilities

  • Provide Quality Engineering support for FDA/ISO compliance
  • Quarantine and evaluate non-conforming products
  • Initiate and manage non-conformance investigations
  • Participate in Material Review Board (MRB) meetings
  • Lead or support Corrective and Preventive Actions (CAPAs)
  • Assist in reviewing and approving quality documentation
  • Initiate and assist with Change Controls

Benefits

  • Comprehensive medical, dental, and vision insurance
  • Competitive 401(k) plan with immediate vesting
  • Generous paid time off and flexible working hours
  • Professional development opportunities including tuition reimbursement
  • Recognition programs for employee contributions
  • Supportive workplace culture with team-building activities
Full 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
  • Computer skills - Microsoft Office Suite (Access, Word, Excel, PowerPoint)
  • Strong decision-making 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.

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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