Sr Analyst, Quality

hace 3 semanas

Tijuana, México BAXTER A tiempo completo

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Overall Purpose of the role:
Reporting to the PMS/Quality Manager and acting as a key member of the International QA Department. The MDR Specialist is responsible for ensuring that Hillrom meets its Regulatory reporting requirements and aligning the teams with a consistent, one Hillrom, global approach to reportable events.

Principal Duties/ Responsibilities:
1. Review decision-trees and other supporting information in Hillroms Complaint System, in order to determine rationale or decision on whether incidents are reportable as per applicable Regulations in conjunction with the Global Potential Reportable Event (PRE) Team. Document rationales/reporting decisions and challenge decisions where necessary and advise PMS QA Manager wherever appropriate.
2. Prepare and file Initial and Final Device MDR Reports, as required, for all Incidents deemed reportable in accordance with reporting timeframes.
3. Liaise with all key stakeholders, (customers, distributors, customer facing teams, service teams, in-country QA personnel etc), to acquire additional information/clarification, as needed, to determine decision on reportability.
4. Liaise with Competent Authorities & Notified Bodies on additional information requests with a view to getting closure on MDRs.
5. Contribution towards the improvement and awareness of all post market vigilance system process activities across all departments throughout Hillrom. Interfacing with other departments and functions, including Operations, Customer Care, Service, Sales and Marketing. Actively seek feedback from internal customers and team members regarding issues and escalate relevant issues to the appropriate people to create an environment of continuous improvement and service excellence. Consult on and identify opportunities for improving the operation of all aspects of the company’s post market vigilance system process activity.
6. Regularly report relevant updates to the team and manager. Proactively seek to keep up-to-date with all information relating to ongoing corporate post market vigilance system process activities and all relevant internal tools, processes, procedures and working practices. Ensure compliance with the relevant legislation and regulations and understand the importance of operating within the guidelines. PMS Specialist will be the central control point for collecting and addressing issues in relation to all aspects of post market vigilance team activities.
7. In conjunction with Corporate Quality Assurance team and the Corporate Potential Reportable Event (PRE)Team the post market vigilance system process activities throughout the International business division:
7.1 Maintain familiarity with FDA Regulations and any associated Directives, MEDDEVs, and national legislation, ensuring compliance with updated regulations, wherever applicable, in accordance with regional and corporate procedures.
7.2 Play a key role in developing, implementing and maintaining the corporate post market vigilance system. Support the reporting process development, implementation and maintenance by defining requirements and providing assistance and support to the PMS Quality manager.
7.3 Supports the global MDR submissions and international vigilance / incident reporting coordination’s development, implementation and maintenance by defining requirements and providing assistance and support for the post market vigilance team.
7.4 Agency communications: Liaise and co-operate with notified bodies and competent authorities in relation to all reportable events. Provide supplementary information to the Competent Authorities, and follow-up with GBUs in a timely manner, in order to ensure that CAs’ timelines are met with regards to MDR reports.
7.5 Facilitate Agency Audit & Inspection management. Liaise and co-operate with quality management teams to support successful NB and Agency audits and inspections.
7.6 Partner with internal stakeholders to utilise post market vigilance data to drive improvements

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to s

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