Quality Systems Specialist

4 weeks ago

Minneapolis, United States Uromedica Inc Full time

Primary Responsibilities: 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.

Supplier Management: Perform supplier controls: performance monitoring and trending, credential reviews, evaluations, and establishing agreements. Set risk-based sampling plans for receipt inspection procedures. Manage Uromedica’s supplier management system. Perform and assist in performing remote and on-site supplier audits including audit planning and auditing report writing.

Document Coordination, Reviews, and Approvals: Coordinate formal Document Change Reviews (DCRs) in the Grand Avenue Software (GAS) quality management software platform. Originate and review DCRs for SOPs, manufacturing, inspection, and test procedures, and product technical documentation.

Grand Avenue Software (GAS): Assist with platform administration, site upgrades, software validations, and change assessments. Manage or assist with managing various modules within GAS, including Complaint Handling, Supplier Management, Training, and Document Control

Corrective and Preventative Actions (CAPAs): Perform CAPA investigations, root cause analyses, corrections, corrective/preventative actions, and verifications of effectiveness.

Gap Assessments: Review applicable standards, regulations, and guidance documents for impact on Uromedica’s QMS and implement required changes.

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

QMS Training Coordination: Help coordinate training tasks. Deliver training presentations, collect and grade training quizzes.

Secondary Responsibilities: Perform receiving inspection activities including inspection, inventory maintenance, and documentation. Manage electronic production inventory management system (Epicor). Assist with purchasing activities. Maintain and manage quality records related to QMS and production activities. Risk Management: maintenance of risk documentation and participation in risk meetings. Audits: Participation in notified body, FDA, and internal audits, including audit responses. Management Review: Data analysis and summary, slide preparation, and slide delivery. Production assistance: assist with order fulfillment, QA release of product, and miscellaneous production operations on a limited basis. Field actions: participation with Health Hazard Assessments and execution of Field Action activities.

Qualifications: B.S. degree in engineering or other applicable discipline or applicable experience/certifications. 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). Proficient 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 oral and written communication skills.

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