TIDI PRODUCTS LLC
Senior Post Market Surveillance Coordinator (Finance)
Supports internal and external quality system audits.
Supports various elements of the Quality Management System, including:
Nonconforming product system, including in-market actions
Complaints and post market surveillance
Corrective/preventative action (CAPA)
Product Design and Development process
Assists in developing and maintaining written procedures, work instructions, and other QMS documentation as required to define and ensure conformance to customer and regulatory requirements.
Performs inspection of customer returned products and collaborates with cross-functional teams to ensure accurate and timely complaint investigations. Routine problem-solving to establish root cause of respective complaints.
Reviews production records to ensure accurate complaint investigations, establishing root cause for respective complaints. Collaborates with cross-functional teams including product engineers and production staff.
Completes Medical Device Record Decision trees and prepares electronic submissions.
Escalates serious complaints to management in a timely manner. Participates in Corrective and Preventative Action Activities ensuring the appropriate product feedback loop is closed.
Performs routine analysis of post-market data and reports results to internal stakeholders.
Become an EtQ and Master Control Software Super User. This will entail analyzing the software to determine regulatory and Posey / TIDI needs, developing rollout plans for new modules, supporting process owners in implementing modules, and supporting on-going maintenance to ensure the software continues to meet process owner and regulatory requirements. Support integration with IBMI and M2K.
Develop and maintain tools and training for Customer Service to facilitate effective troubleshooting and clear documentation of complaints upon receipt.
In the event of a field action, be a key team member in the follow-up and monitoring of the action, including providing status updates to Management and facilitating the appropriate and timely MDR filings.
In addition to complaint responsibilities, this role may take on ad hoc responsibilities within the Quality department at the discretion of the Quality System Manager.
This position has no direct reports; however, this position is expected to lead and/or direct others on a project assignment basis, managing projects and team members to ensure timely and effective completion of deliverables including providing guidance, coaching and/or training
CORE VALUES & GUIDING PRINCIPLES:
Understands internal and external customers
Assure a safe work environment
Encourage individual development
Demonstrates teamwork and flexibility/adaptability
Demonstrates honesty
Keep our commitments
Think systemically and ensure constancy of purpose
Lead with humility and respect every individual
Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection