Senior Quality Complaint Analyst - Tijuana, México - Outset Medical

Outset Medical

Empresa verificada

Tijuana, México

hace 1 semana

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Company Overview
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis.

The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers.

Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone.

The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.

Position Overview
Responsible for monitoring and managing all areas of Complaint Handling activities. Monitors metrics and drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions. Initiate and facilitate corrective or preventive actions as needed. Ensure quality customer and regulatory communications for current products. Assist in ensuring compliance with evolving Global Requirements and Regulations such as MDSAP and EUMDR. The incumbent for this position will support additional activities as assigned.

Essential Job Functions and Responsibilities

Be part of the Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and nonreportable product complaints in accordance with established company procedures and worldwide regulations and standards. Contribute to continuous improvements to Complaint Handling process.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
Collaborate with Customer Support, Engineering, and Service teams to support complaint activities
Perform reportability determinations in conjunction with medical advisor as necessary.
Provides information for timely Adverse Event reporting.
The role requires awareness of new or revised regulations and/or guidelines.
Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
Excellent interpersonal skills
A selfstarter, motivated and able to positively motivate others
Focused, target driven with a positive, cando attitude
Support of additional Quality Systems activities, as requested.

Required Qualifications

Bachelor's Degree in engineering or technical field or equivalent.
Minimum of 3 years of relevant Complaint Handling experience in a regulated industry.

Desired Qualifications

Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Highly organized and detail oriented with strong followup skills to manage large volumes of documentation. Ability to understand priorities.
Ability to work independently and address obstacles that may arise.
Ability to work in fast paced and dynamic environment.
Strong analytical skills.
Excellent written and verbal communication skills.
Fluent in English (both written and verbal)
Accuracy is required in performing all functions of this position.
Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat.
Lead Auditor certification a plus.