Beschreibung
A multinational medical device company is looking for multiple complaints management specialists to support the Complaint Management team in a Quality Improvement program with multiple projects.The scope of the projects will be to drive compliance with FDA/GMP requirements and to improve internal communication.
Start: July 2014
Duration: 12-18 months
Location: Canton Zurich, Switzerland
Responsibilities
Support projects within the complaints team including:
Post market surveillance
Field action procedures
Vigilance reporting
Market withdrawal including lot tracking and lot blocking
Review related documentation to improve adherence to regulatory requirements
Review complaint SOPs and align to best practice and regulatory requirements
Provide input relating to strategy and ideas for improvement and advise the department within scope and ensure implementation of quality related knowledge, procedures and guidelines
Support the drive to improve the feedback loop from post market surveillance into the design control process
Help to determine ongoing processes for quality and regulatory requirements for new products
Job requirements
Extensive experience in a GMP/Quality related role within medical device or pharmaceutical industry
Experience in complaint management
Experience with continuous improvement and lean thinking, is an asset
Quality and compliance driven
Good interpersonal skills
Ongoing focus on identification and realisation of improvement potential
Good written and oral communication skills in English essential