Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.
Learn about us on www.wsa.com
Your new role
- Ensure screening of incoming complaints for potential reportability
- Ensure complaints are assigned to the correct investigator for timely resolution
- Ensure complaints are processed in a timely manner; follow ups with investigators performed and other members of the organization as needed
- Ensure complaint files are documented as per applicable procedures and regulatory requirements
- Ensure review and closure of complaint files is performed to ensure all activities were performed and documented as per applicable procedures
- Act as main point of contact for the organization for European complaints, sample processing and investigation as applicable
- To provide guidance for sale companies/affiliates/distributors/etc. on complaint handling processes.
- Develop and maintain training material/procedures for the complaint handling processes and systems
- Closely work with Designated Complaint Unit colleagues to identify, develop and implement process improvements related to complaint handling
- Support during Internal/external Audits for backroom, front room, SME, etc.
- Assist in preparing local management reviews in providing complaint related data and any other additional data as required
- Assist in reviewing local CAPAs, MIR Reports and CAPA checks as required
- Participate in developing and delivering the QMS strategy and associated tasks as required
- Industry; preferably medical devices.
- Knowledge of Quality Standards and Quality Systems Requirements in Medical Device Industry worldwide
- Knowledge in managing of customer complaints and associated processes
- BSc in Science or Equivalent
- Experience working with colleagues overseas in US, Europe and Asia
- ISO 13485, CFR/GMP, MDD, MDR, MPG
- Experience in Hearing Aids Industry.
- Knowledge of Post Market Surveillance, Complaint Handling standards and regulations is preferred
Performance and personal competencies:
- Team player
- Good communicator with sense of urgency
- Good aptitude of challenging status quo
- Fluent in English (Spoken, Written)
- Presentation and Training Capabilities
- Attention to detail
- Analytical and process oriented
- Ability to work in a matrix environment across multiple countries
What we offer
- Employment in a stable company with an established position in the market
- Good working environment
- Challenging problems to solve
- Package of benefits such as private medical insurance, sport card, integration and family parties, holiday’s bonus, life insurance
Join WS Audiology
Please submit your application as soon as possible. We will screen and invite candidates for interviews on an ongoing basis.