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Outset Medical // improving patient care experience
 
3052 Orchard Drive San Jose, California Headquarters    Posted: Wednesday, September 22, 2021
 
   
 
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JOB DETAILS
 

Company Overview

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost & 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 &  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 & by anyone.  The integration of water purification & on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission &  a proprietary data analytics platform powering a new holistic approach to dialysis care.  

 Position Overview

Responsible for monitoring & managing all areas of post market surveillance activities such as complaint & Adverse Event reporting.  This includes the investigation of product malfunctions, product design and/or labeling, as well as customer dissatisfaction issues, & the regular monitoring & reporting of complaint handling status. Monitors metrics & drives process improvements based on performance trends. Ensure proper analysis of product quality, safety, & reliability issues & effective communication to management & other functions. Initiate & facilitate corrective or preventative actions as needed. Ensure quality customer & regulatory communications for current products. Is responsible for the maintenance of SOP & work instructions related to Post Market Surveillance & Complaint Handling process requirements, that ensure compliance with evolving Global Requirements & Regulations such as the EUMDR.  Responsible for providing leadership, outstanding people skills & management to a team of Complaint Analysts.  The incumbent for this position will support additional activities as assigned.

Essential Job Responsibilities

  • Contribute to continuous improvements to Complaint Handling process
  • Provides timely Adverse Event reporting.
  • Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation & timely closure of each complaint
  • Collaborate with Customer Support, Engineering, & Service teams to support complaint activities
  • Generate complaint trending reports for analysis
  • Support & participate in internal & external audits
  • Assist in generating complaint data reports for QRB & Management Review Meetings
  • Ensures complaint data is aligned with the Risk Management File & activates action plan when needed.
  • Develop & maintain product knowledge of existing & new products
  • Provides routine metrics/analysis monthly & quarterly.
  • Provide feedback/direction to team members.
  • Provide responses to Regulatory Authorities.
  • Provides feedback to the post market Risk Analysis process.
  • Works closely with the Quality leadership team to establish Quality Performance Metrics & Complaint Reports, analyzes quality data to identify tends & reports them to management in a timely fashion.
  • Supports the Corporate Corrective & Preventative Actions (CAPA) program, with particular emphasis on CAPAs escalated from Complaints.
  • Perform reportability determinations in conjunction with medical advisor as necessary.
  • Lead Complaint Handling Unit & cross functional team of individuals through completion of investigation & closure of reportable & non-reportable product complaints in accordance with established company procedures & worldwide regulations & standards.
  • The role requires awareness of new or revised regulations and/or guidelines.
  • Reviews & continuously leads efforts to improve the global complaint handling & post market surveillance processes.
  • Authors & approves response communications to inquiries from regulators.
  • Supports internal & external audits (e.g. FDA) of complaint handling function.
  • Serve as a backroom subject matter expert (SME) for complaint processing, complaint investigation & MDR reporting during audits & inspections.
  • Develop & maintain strong relationships with internal & external stakeholders to ensure optimal performance
  • Excellent interpersonal & leadership skills
  • A self-starter, motivated & able to positively motivate others
  • Focused, target driven with a positive, can-do attitude

People Management:

  • Manage, coach & develop a high performing Quality team that meets agreed objectives & which delivers best practice results, added value & continuous improvements
  • Set department objectives/KPIs & review & assess ongoing performance of direct reports
  • Report on achievement of targets & identify any actions required
  • Manage & lead the team
  • Motivate & coach the team to operational success

Requirements/Qualifications

  • Bachelors degree in Engineering, Medical or Science (or similar).  Masters degree preferred.
  • Minimum of 7+ years of hands on experience with increasing Quality Assurance responsibilities or similar field. A minimum of 2 years Management experience.
  • Prior experiences in a medical device regulated environment.
  • Ability to work effectively in a fast paced & dynamic environment.
  • Leadership & interpersonal skills to develop & manage good working relationships with internal departments
  • Strong written & verbal communication skills.
 
 
 
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