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Senior Complaint Handling Specialist

Visby Medical

Visby Medical

Quality Assurance
San Jose, CA, USA
Posted on Saturday, May 11, 2024

About Visby

Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.

About the job

The Senior Complaint Handling Specialist will support the growth and continuous improvement of the Quality System, providing a high level of hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day to day complaint review, complete investigation reports, adverse event reporting and maintaining the complaints log and trends. The Sr Complaint Handling Specialist will work closely with and will provide direct day-to-day support for the Customer Experience Team.

How you’ll make an impact

  • Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, European Vigilance Reporting.
  • Support and participate in internal and external audits, risk management summaries and health hazard evaluations.
  • Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure.
  • Ensure timely completion of MDR and Vigilance reporting, as well as initial, supplemental and final incident reports to regulatory authorities within specified timelines.
  • Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.
  • Evaluate all information from a technical perspective to ensure appropriate analysis and investigation
  • Maintain comprehensive records of customer interactions, complaints, and resolutions in the company's database or customer relationship management (CRM) system.
  • Work directly with Customer Experience to support and triage incoming customer calls. Consolidate customer feedback and insights to build the Visby product knowledge base.
  • Exhibit empathy, patience, and active listening skills when interacting with customers to ensure a positive customer experience. Communicate technical information clearly and concisely to both technical and non-technical stakeholders.
  • Other duties as assigned

On your first day we’d like you to have

  • Bachelors degree and/or a minimum of 5 years of related experience in the in-vitro diagnostics or medical device industry.
  • Strong problem-solving skills, critical thinking, and experienced at investigating and resolving complex technical issues.

It’s great if you have

  • Etq Reliance QMS experiences is a plus
  • Salesforce experience is a plus
  • Customer service experience is a plus
  • Excellent written and interpersonal communication skills.
  • Strong technical understanding of IVD troubleshooting.

Unique aspects of this job

  • Travel: Minimal travel (~5%)
  • Schedule: This is a hybrid role, onsite a minimum of 3 days a week. Flexibility to be onsite as business dictates. Can include any deviation from standard M-F onsite.
  • Physical aspects: Comfortable performing repetitive tasks and/or motions. Must be able to lift a minimum of 10 lbs.

Salary range

  • $95,000 - $115,000 (salary range for candidates based regionally)
  • Compensation for the role is based on geographical location. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly.
  • Compensation also depends on a number of factors including a candidate’s qualifications, skills, competencies and experience and may fall outside of the range shown.

More about our benefits

Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer a 401k match, flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.

Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.

Additional information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.

Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.