Quality Complaint Analyst

hace 2 semanas


Tijuana, México Outset Medical A tiempo completo

**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**
- Investigate reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards.
- Contribute to continuous improvements to Complaint Handling process.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Maintain 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.
- Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
- Excellent interpersonal skills
- A self-starter, motivated and able to positively motivate others
- Focused, target driven with a positive, can-do attitude
- Support of additional Quality Systems activities, as requested.

**Required Qualifications**
- Bachelor's Degree in engineering or technical field or equivalent.
- Minimum of 1 year experience working in a regulated industry or similar manufacturing and engineering environments preferred.
- Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (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 follow-up skills to manage large volumes of documentation.

**Desired Qualifications**
- 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. Salesforce Experience a plus.

Privacy is important to us. Please review our **Applicant Privacy Notice.**

**EQUAL EMPLOYMENT OPPORTUNITY STATEMENT**

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.


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