Kelly Scientific Resources is a competent and experienced partner of the life science industry. Our client is a global player with multiple sites in Switzerland spearheading the development of implants used in trauma surgery.
To elevate the local understanding and execution of quality guidelines, we are looking for multiple
Improve and maintain products and processes including : Site Validation Master PlanRisk Management Product quality issue resolution and critical issue, High-
Risk CAPAsQuality systems performance monitoring, Inspection plans
Final review of intra and inter-departments collaboration plans with Product Management, Regulatory / Medical Affairs, Design Quality
Development of Process Failure Mode Effects Analyses (pFMEAs)
Push Non-conformity & Recall Prevention as well as Audit Readiness initiatives
Direct report and lead of the Quality Engineer team
Professional Experience :
Degree in Engineering or technical field
5 years experiences in an FDA or European regulated environment
A thorough understanding of GMP / ISO regulations
Relevant background in manufacturing / operations
Technical training and experience using statistics, Lean and Six Sigma
Experience in complaint management & Non-conformity remediation
Fluency in English and ideally German
Are you the person we are looking for? Then apply online today!
Mr Roman Freitag (Tel : +41 (0) 44 225 41 08) is happy to answer your questions.
Kelly Services (Schweiz) AG, Löwenstrasse 29, 8001 Zürich, Opening hours Mo- Do : 08.00 12.00 Uhr / 13.30 17.30 Uhr Fr : 08.
00 12.00 Uhr / 13.30 17.00 Uhr