Quality Systems Specialist - Plymouth, United States - Uromedica, Inc.

Description

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.