Consumables Owner - Zug, Schweiz - ITech Consult

ITech Consult

Geprüftes Unternehmen

Zug, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Consumables Owner (M/F/d) - ISO 13485 /
FDA 21 CFR / Risk Management / English / German**
Project:For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Consumables Owner (M/F/d)

Background:
Global Operations Consumables is the competence center for single-use injection molded parts in the diagnostic workflow.

This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

It has expertise in all injection molding and plastic-relevant areas: Mold technology, polymers, automation, product design, supplier management, injection molding technique, plastics technology and material sciences.

A Consumables Owner is the focal point for your designated products and works in an interdisciplinary team ensuring a holistic view of necessary activities.

In this position the consumables owner has versatile and varied responsibilities interacting with Suppliers, Supply Chain, Quality and Regulatory as well as System Development and Business Management ensuring continuous learning and development.

Together with the team members the person has the possibility to exercise leadership, enfolding the swarm intelligence of the people surrounding.

The need to visualize complex interdependencies for fact based decision making ensures ample opportunity to use communication and presentation skills.

Tasks & Responsibilities:

Accountable for assigned product(s)
Accountable for Product

- /Production-issues and risks

Owner of product specification and production process specification
Accountable for product changes, complaints and deviations
Accountable for spare part management
Accountable for production assets and equipment
Accountable for the overall Squad performance w/r to quality, supply, compliance, cost
Ensures a clear, strategic Squad view on prioritization and OneRoche mindset
Develops and implements the product wide production capacity plan and output report in collaboration with the relevant functions in accordance with the Product Strategy and provides information to Network Lead
Acts as the final decision maker within Squad e.g. prioritization
Manages all key stakeholders at Squad level (internal and external)
Represents Consumables in Business Teams on PCQT level, represents Consumables in system development projects
Interacts with business (e.g. IPM) to understand demand forecast, its development and fluctuations and triggers follow up actions
Compiles Annual Product Review Report in collaboration with all relevant stakeholders, including triggering actions, risks and mitigations
Chairs Product Meeting with supplier and subsuppliers at an operative level
Chairs the Squad and provides necessary leadership to the team members to assume their accountabilities
Responsible for Squad budget (e.g. OPEX/CAPEX, development budget, PCQT budget)
Manages SMC cost account including budget planning and search for potential savings
Provides feedback to Chapter Leads on Squad Members
Executes Operatives Risk Management
Plans replacements and new investments and calculates business cases
Understands contracts with suppliers as regards of content
Monitors the supplier safety stock target and in Roche hub targets
Owns and maintains product documentation during Product Life Cycle

Must Haves:

University degree in Engineering, Natural Science or related disciplines
Min. 3 years of work experience in IVD product management and production engineering
Knowledge of Process Management methodologies (Lean, Six Sigma, etc.) and invitro diagnostic related regulations, such as ISO 13485, IVDR, FDA 21 CFR part 820 etc.
Experience in IVD product development following design control, manufacturing and testing
Leadership skills including the ability to get things done with a proven track record of consensus building and conflict management in challenging situations, eg. in a project leader role
Ability to think strategically and systemically, willingness to try new ideas and participate in changes
Selfmotivated, autonomous, structured and goaloriented mindset with a solution oriented balance of short term mitigation and long term solution
Ability to effectively communicate with all levels of the organization by establishing credibility and building rapport
Executive presence, performing well under pressure and decisiveness
Excellent communication skills in English and min. good communication skills in German
Travel required 1020%

Nice to have:

First professional experience in Supply Chain Management/ Procurements as an interface
Experience in a highly regulated production environment (clean room facilities)
Experience with the design, construction and commissioning of highly automated production plants

Reference Nr
:

922638TP

Role:

Consumables Owner (M/F/d)
*