Quality Engineering & Assurance

Quality Engineer
Quality Assurance
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.
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.
Non-Conforming Materials (NMRs):
Issue and approve NMR dispositions including risk assessments and rework instructions.

Management Review: Data analysis and summary, slide preparation, and slide delivery.
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.
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.

Experience with Grand Avenue Software (GAS) Electronic Quality Management System (Preferred).
Proficient knowledge of internet and Microsoft Office Applications (Word, Excel, and PowerPoint required; Access, Project and Visio preferred).
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. 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.
Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
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: Participate in team-building activities, volunteer opportunities, and company-sponsored events. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Employing about 16,000 people and with products available in more than 143 countries, we are one of the world s leading medical device companies. Watch the film. Follow us on LinkedIn .
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.