For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified andmotivated Product Leader for 1 year with option for possible extension.
The team of around 20 highly motivated Product Leaders that maintain over 45 products produced by InstrumentOperations Rotkreuz or by selected OEM Partners along the entire product life cycle, from the early concept drawingthrough pilot and series production till the market phase out.
Therefore, some Products Leaders are involved in development projects of new products assuring the implementation ofOperations requirements and aspects including Design for Quality and Manufacturability (DQM) and Cost of Goods Produced(CoGP) targets.
Others are involved in all technical aspects of a product and its continuous cost optimization in thepost launch product care phase.
A central element to manage this broad span of complexity are the so-called Product Teams, which are led by theProduct Leader.
This cross-functional platform enables timely and close collaboration with all involved functionsincluding Development, Quality, Global Customer Service (GCS), Case, Investigation & Resolution Unit (CIR), RegulatoryAffairs and Global Supply Chain.
As member of the Product Care & Quality Team (PCQT), the Product Leaders reports tothe PCQT Head and is in regular contact with the Operations Functional Leads and the Business Area.
responsible for all underlying project management activitiesincluding planning (time, cost incl. CAPEX / PQ & PI budgets, resources, quality), delivery of underlying work results,monitoring and tracking, reporting, alignment with involved Functions within & outside Operations- Leads the Product Care Budget Planning- & Alignment Process according to PCQT- (PQ-part) and Operations (PI-part)guidelines, responsible for budget monitoring- Drives the SMC (Standard Manufacturing Costs) optimization process for his / her products, develops & aligns jointlywith Production, Technical Support, Logistics Support, Strat.
Procurement best possible solutions in respect to costs,manufacturability, testability, logistics; takes the Total Cost of Ownership for Roche into consideration (incl.
service costs & complaint RCA)- Responsible for implementation of CAPA process according to QMS requirements- Responsible for blocking of non-conform products according to QMS requirements- Responsible for implementation of Change Management Process according to QMS requirements- Responsible for implementation of DQM (Design for Quality & Manufacturability) for his / her products within the givenenvironment & life cycle stage- Defines and tracks with his / her Product Team the yearly cross-functional Product Care objectives (incl.
TAT, MTBRV,Right first time (RFT), Spare Parts Costs, ProCare Budget), aligns these with impacted Functions & Stakeholders- Responsible for the continuous Product Risk Management Process and resulting updates to the Risk Management Fileduring the Post Launch phase until product phase out- Responsible for the Risk Assessment of the instrument manufacturing processes (process-FMEAs) in close cooperationwith the responsible Head of Production & Production Team Leads- Representation of Global Operations in the R&D project teams- Leads the Product Problem Meetings (PPM) on request, acts as interface between PPM and Product Team- Contact to Operations Functional Leads for all Product Lifecycle Management activities- Member of the responsible PCQ Team (Product Care & Quality)- Supports demand planning in close alignment / cooperation with BA-PCQT, Logistics, Production, potentially Affiliatesfor his / her product- Creation and tracking of supplier engineering change requests with involved internal Functions and external partners- Execution of technical content reviews (incl.
risk assessment, need & quality of underlying documentation forverification & validation) with external partners (suppliers, development partners)- Supports the continuous improvement of the Roche end customer experienceMust Haves- Academic degree in Life Sciences or Engineering, PhD and / or MBA of advantage- At least 3 years of professional experience in Medical device environment within a producing company- At least 3 years of professional experience in a highly regulated environment and with regulatory affairs.
willingness to proxy department head on a need basis- Courage to speak up, standing in case of cross-wind- Has very good communication & presentation skills (acts as role model)Nice to Haves- Roche experienceAre you interested?
Do not hesitate and submit your complete application documents online today.We value diversity and therefore welcome all applications - regardless of gender, social origin, religion / belief, ageor identity.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearingfrom you!