Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective medical products in the install base across Healthcare. Impacts quality of own work and the work of others on the team, including analysis and documentation of complaints, presentation of trends, identification of reportable events per the various regulatory authorities in the world. The role includes close work with internal interfaces such as engineering teams, production, service, quality assurance and regulation.
Roles and Responsibilities:
Handle complaints as part of a complaint handling unit and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of Healthcare products.
Autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures.
Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
Facilitating complaint investigations and engaging product design owners to determine effective CAPA.
Roles and Responsibilities:
Handle complaints as part of a complaint handling unit and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of Healthcare products.
Autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures.
Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
Facilitating complaint investigations and engaging product design owners to determine effective CAPA.
Requirements:
achelors degree in Engineering and minimum 2 years work experience in Quality or Regulatory Assurance related field.
Minimum 2 years work experience in biomedical, mechanical, electrical or software product development and design.
achelors degree in Engineering and minimum 2 years work experience in Quality or Regulatory Assurance related field.
Minimum 2 years work experience in biomedical, mechanical, electrical or software product development and design.
This position is open to all candidates.
