QM Process Specialist

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Stuttgart, Baden-Württemberg
In-Office
Healthtech
The Role
Company Description

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’700 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).

www.medmix.swiss

Job Description

  • Support with the implementation of our global QMS and act as ambassador for it by delivering trainings to the users
  • Write global policies, taking into account lean and least burdensome principles and applicable laws, standards and internal requirements. Ensure alignment with site responsible functions prior to roll-out
  • Help to create and structure the global process landscape, gathering feedback and continuously analyzing improvement needs
  • Coach local process owners in interpreting global process expectations, support process owners with process issues/problems and reviewing for improvement opportunities
  • Ensure consistent and timely quality KPI reporting at global and BU level, collect and review site KPI information for consistency of data and trends
  • Assist the Quality Managers in defining data sources related to quality KPI reporting
  • Support Global and Local Quality Management as requested in cross-site activities to resolve business critical issues in the marketplace (e.g. complaints, CAPA's, audits or similar)
  • Act as Business Application Owner for medmix document management system

Qualifications

  • University degree in technical engineering or life sciences or higher specialized training in a technical or scientific field with extended training in standards and tools relevant to quality management
  • Experience in Quality Management in the field of Medical Devices
  • Extensive practical experience of handling typical quality tools like complaints, non-conformities, CAPA and Audit as well as basic understanding of handling quality topics in a production environment
  • In-depth experience with laws and standards related to Medical Devices (e.g. ISO 13485, MDR, QSR.)
  • Proficient experience in implementing and adapting software tools (ERP, MES, CAQ and DMS, Excel) for quality purposes
  • Proven ability to easily convey complex relationships to different audiences
  • Very good knowledge of written and spoken English and German (C1 Level for both)
  • Flexibility in daily working hours as required to accommodate different time zones for online collaboration

Additional Information

At medmix you will work in a highly motivated, international team with dedicated people who put the needs of patients at the center of their doing. You will receive for example following benefits:

  • Flexible hybrid working environment
  • 30 days’ vacation
  • Possibility to work remote up to two days a week
  • Company pension plan
  • Capital-forming benefits
  • Discount of public transportation (Deutschlandticket)
  • Pluxee Card Benefit with monthly budget
  • “Corporate Benefits” and “Benefits me” apps for discounts
  • Regular company events

medmix is an equal opportunity employer, committed to the strength of a diverse workforce.

93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today!

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The Company
HQ: Zug CH
802 Employees

What We Do

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 15 production sites worldwide together with our highly motivated and experienced team of over 1’900 employees provide our customers with uncompromising quality, proximity and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

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