Quality Engineer

Quality Engineer

Location: Plymouth, MN, US Job Family: Quality Assurance Country/Region: United States

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:

• Supplier Management: Perform supplier controls: performance monitoring and trending, credential reviews, audits, evaluations, and establishing agreements. Set risk-based sampling plans for receipt inspection procedures. Manage Uromedica's supplier management system.
• 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.
• Non-Conforming Materials (NMRs): 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.

Coordinator Role(s): 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.

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.