Responsibilities
- Initiating complaints and ensuring all required information is gathered and added to the complaints file in an accurate and timely manner.
- Monitor and lead the reporting inbox(es) for global complaint intake.
- Communicate with Customers, internal stakeholders, and field representatives in a professional manner to gather complaint information.
- Escalating adverse events per processes and/or procedures, when applicable.
- Supporting service and repair events including evaluation of intake information and review of repair activities to assess whether a complaint is warranted.
- Ensuring complaints are prioritized based on patient, product, and compliance risk.
- Facilitating complaint device returns investigations.
- In conjunction with internal team, Engineering and/or Clinical, completing complaint records/investigation reports using concise and grammatically correct English (appropriate for regulatory review).
- Assisting in reviewing and closing complaint files/records in a timely and accurate manner.
- Supporting of ad hoc complaint metrics and data requests from key stakeholders such as regulatory, clinical, R&D, quality, and manufacturing.
- Ensure associated communications are appropriately disseminated and documented as per the complaint file and/or additional requests.
- Maintaining QA related logs and databases (e.g., Complaints, MDRs etc.)
- Other duties as assigned.
Requirements
- Minimum of 1-2 years related work experience is required.
- Bachelor’s degree in engineering, science or nursing or the equivalent work experience.
- Working knowledge of FDA processes for medical device compliance (e.g. 21 CFR 803 and 820)
Nice to Have
- Experience with either Master Control and/or Trackwise
- Working knowledge of organ perfusion medical terms
- Knowledge of adverse event/vigilance reporting to UK, EU, Canada and/or Australia
Benefits
- competitive compensation
- comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
- 401(k)-retirement plan with company matching after 90 days
- paid time off, holidays, and additional leave benefits
- employee discounts and access to our onsite wellness facility.
Work Arrangement
Hybrid
Additional Information
- This role may require travel up to 10% (including travel to the U.K.)
