Quality Assurance Specialist
As a global leader, WS Audiology continues to pioneer the use of technology to help people with hearing loss enjoy the sounds that make life wonderful.
Our Quality team is currently looking for a QA Compliant Unit Specialist to join the team, with key responsibility to assures that customer complaints are captured, assessed for reportability, processed, investigated and resolved in a timely matter as per applicable internal and regulatory requirements
You will specifically be expected to:
Complaint Handling - DCU Designated Complaint Unit - (QA Customer Service & Sales)
- 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
Other Quality related tasks:
- 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
The successful candidate will be an experienced professional, preferably with quality assurance domain expertise. S/He will have excellent communication and people skills to work with cross-cultural teams across geographies.
- At least 2 years’ experience in Quality, Quality Management Systems within regulated 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
- Knowledge of Post Market Surveillance, Complaint Handling standards and regulations
Interested applicants, please submit your application online. We regret that only shortlisted applicants will be notified. Thank you!