Quality Systems Specialist

2 weeks ago


Plymouth, 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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