Quality Engineer

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The Quality Engineer is responsible for supporting and maintaining quality compliance and will recommend and implement process improvements. This position is central to maintaining the compliance of various aspects of the Quality Management System (QMS) in close collaboration with a small team. In all actions, this position demonstrates a primary commitment to patient safety and product quality.

Major Areas of Accountability

• Perform supplier controls: performance monitoring and trending, credential reviews, audits, evaluations, and establishing agreements.
• Set risk-based sampling plans for receipt inspection procedures.
• Document Coordination, Reviews, and Approvals:
  • Originate, coordinate, and review formal Document Change Reviews (DCRs) in the Grand Avenue Software (GAS) quality management software platform.
• QMS Training Coordination:
• Coordinate training tasks. Deliver training presentations, collect and grade training quizzes.
• Complaint Handling and Returned Goods Authorizations (RGAs):
  • Manage Uromedica’s complaint handling module including entering, investigating, reporting, and trending complaints.
  • Enter complaint information into post-market surveillance data.
  • Issue and track RGAs, coordinate returns with sales and marketing.
  • Performed returned device evaluations.
• Corrective and Preventative Actions (CAPAs):
  • Perform CAPA investigations, root cause analyses, corrections, corrective/preventative actions, and verifications of effectiveness.
• Issue and approve NMR dispositions including risk assessments and rework instructions.
• Audits:
  Participation in notified body, FDA, and internal audits, including audit responses.
• Management Review:
  Data analysis and summary, slide preparation, and slide delivery.
• Review device history records to ensure records are completely and accurately filled out.
• Perform gap assessments
• Assist manufacturing/operations projects as needed.
• Field actions: participation with Health Hazard Assessments and execution of Field Action activities.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.
• Specified on LOG 100250.

Signature Authority:

• Specified on LOG 100250.

Basic Qualifications

• B.S. degree in engineering or other applicable discipline or applicable experience/certifications.
• Minimum 1-3 years applicable experience in medical device quality management systems.
• Working knowledge of medical device regulations (Regulation 2017/745 (EU MDR), US 21 CFR Part 820).
• ASQ Certified Quality Engineer preferred.

Required Knowledge, Skills and Abilities

• Working knowledge of ISO 13485.
• Experience with Grand Avenue Software (GAS) Electronic Quality Management System (Preferred).
• Capable of independent self-led initiative in a dynamic work environment.
• Demonstrated ability to work in a team environment.
• Proficient knowledge of internet and Microsoft Office Applications (Word, Excel, and PowerPoint required; Access, Project and Visio preferred).
• Excellent attention to detail.
• Excellent oral and written communication skills.

  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,…