Team Coordinator Global Medical Device Management
F. Hoffmann-La Roche Ltd
Basel Headquarter,Basel-City,Switzerland,
vor 6 Tg.

The Position

We are seeking an experienced and self-initiated leader to join our Supplier Quality Global Medical Device Management Team (MDM) in the External Quality Organization.

Our purpose is to maximize the capability of the external network worldwide to deliver products to patients when they need them, in collaboration with our Suppliers.

The Team Coordinator works independently yet collaboratively, and leads Supplier Quality Oversight activities across the product lifecycle, from supplier selection during development to clinical and commercial production activities at supplier sites, for purchased medical devices, medical device components and constituent parts for Device Combination Products (Medicinal Products).

In this role, you will operate as the primary quality point of contact to Suppliers for development and commercial products and establish productive partnerships to ensure robust processes and supply to Roche sites globally.

You will be responsible to identify and drive continuous improvements internally and at Supplier sites applying LEAN principles.

This role provides an opportunity for you to serve as a technical back-up for the department head and also represent MDM in a leadership capacity at management and project meetings internally and externally.

You will lead team huddles, supplier performance reviews, and establish a communication plan within the MDM Team and across the Supplier Quality platforms, development teams, procurement and other business partners and stakeholders to ensure alignment across the Roche network.

Your key responsibilities require you to influence internal and external leadership and execute in areas such as the following :

  • Evaluate and solve a wide range of complex issues that affect multiple functions / sites related to medical device discrepancies, market complaints and associated investigations, in accordance with the applicable regulations, guidelines, GMP and Roche standards
  • Initiate, assess, and manage supplier-related changes in accordance with applicable regulations, guidelines, and Roche standards
  • Monitor and Trend the performance and risk level of assigned Suppliers, Identify, Define and
  • Implement Supplier corrective and improvement projects by proactively collaborating with Functions / Sites and Suppliers to enhance the quality and supply of direct materials
  • Create and Negotiate Quality Agreements. Provide quality requirements and negotiate final Supplier Specification.
  • Participate in due diligence assessment for Supplier selection, lead Supplier qualification and maintain its approved state through consistent satisfactory performance.
  • Who you are

    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

    Where a job title is not considered the final definition of who you are, but the starting point.

    You have a Master or university degree in engineering, pharmacy, life sciences or equivalent. You have at least 12 years of experience in the pharmaceutical or medical device industry in the area of Supplier Quality, Quality Engineering, Device Development, Process Engineering or Production, or an equivalent combination of education and experience.

    Additionally, you possess the following experiences and competencies :

  • Hands-on experience in medical device manufacturing
  • Demonstrated capability of applying risk management concepts and tools, and Design Control
  • Sound knowledge of GMPs and Quality Systems for Pharmaceuticals, Biologics and Medical Devices, ISO standards and applicable international regulations, including but not limited to 21 CFR Part 4 and Part 820, ISO 13485, ISO 14971, ISO 9001, EU Medical Device Directive
  • Demonstrated teamwork, collaboration and influencing skills and relationship management with third parties
  • Ability to communicate clearly and professionally both verbally and in writing in English; German would be beneficial
  • Demonstrated problem solving and decision-making skills including hands on working experience with basic statistical tools.
  • Six Sigma / LEAN knowledge is preferred

    This position requires travel up to 30% within and outside of Europe.

    Please apply until : 10 September 2018.

    For questions please call the Recruiting Team Switzerland : +41 61 682 25 50.

    Roche is an equal opportunity employer.

    Roche is an equal opportunity employer.

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