Beschreibung
Product Leader - Development/CAPA/Regulatory
Project Task:
-Leads the Product Team for his/her Projects (eg New Development/Product Update) and Products (Post Launch) in Instrumentation Operations
-Responsible for planning and monitoring of required schedules, costs and resources
-Responsible for implementation of Design for Quality and Manufacturability/Cost/Serviceability Responsible for all Design Transfer activities incl. proto and pilot delivery
-Responsible for Risk Management (Manufacturing Process), CAPA- (Y2), Change- and Configuration Management for his/her products
-Initiation of Product Care projects and activities, driving the entire planning process, negotiation and alignment with responsible PCQTs and other impacted Product Teams (in case of multi-use components)
-Leads yearly Product Care Budget and CAPEX Planning process for his/her products
-Responsible for the maintenance of Product Risk Management File for his/her products
-Drives the continuous Standard Manufacturing Costs (SMC) Optimization Process for his/her products
-Responsible for definition of yearly product objectives
-Primary contact for Operations Functional Lead and Head of PCQT, representative of Global Operations in his/her PCQT and R&D project teams
Skills/Requirements:
* Experience in working in a Matrix and on an operational level
* Good process knowledge: Product Care, Change Management, CAPA, Configuration Management
* Basic understanding of Regulatory Affairs and our regulated IVD environment
* Experience in SAP, Microsoft Office, Google Tools
* Courage and standing to challenge and optimize way of working and processes eg in the interface with Business Units or Global Functions
Education:
* Solid background in Engineering (SW, HW, FW, Material Science), optional: higher academic degree (PhD, Master)
* Project Management certificate (eg PMP by PMI, IPMA-Level A, B or C)
Language:
* German fluent and English
Reference: 917907NC
Role: Product Leader- Development/CAPA/Regulatory
Branch: Medical
Location: Luzern und region
Workload: 100%
Start date: From 01.01.2019
End Date: Till 31.12.2019
Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via den Link in dieser Anzeige. Falls diese Position nicht so gut zu Ihrem Profil passt und Sie sich wünschen, andere Position direkt zu erhalten, können Sie uns Ihr Dossier ebenso via diese Anzeige oder an jobs[at]itcag[dot]com zukommen lassen.
Kontaktieren Sie uns für weitere Informationen über unser Unternehmen, unsere Positionen oder unser attraktives Payroll-Only-Programm.
Über uns:
ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von IT-Kandidaten für Auftragsarbeiten. Wir wurden 1997 von IT-Profis gegründet und wissen daher, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist.