Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Over 5 years
Required language knowledge
English German

Details

Location
Other countries
Term of employment
Temporary
Sector
Medical technology
Professions
CNC / Machine operator Design / CAD / CAM Quality Control / Processes Management / Project Managemen... Electronics / Electrotechnical Alternative / Renewable energy Environment / Safety Engineer / R & D Mechanic (Precision / Micro /... Car Mechanic / Car Electrician... Preparatory Work / Production Manual Worker / Qualified Manu... After-Sales Service / Maintena... Speciality of Watchmaking Technical-commercial Business- / Requirement Analys... Consulting / Management / Proj... SAP Project Management / Consu... Data Warehouse / Business Inte... Software Development / Softwar... Web Development / Publishing /... ERP (Oracle, Sage, Infor, Micr... Helpdesk / Support / Training Networks / Security / Hardware Database specialist / Architec... SAP Basis / Module Specialist System Technician / - Administ... Testing / Audit / Release Mana...

Description

Temporary QA Manager position - Supervisory and hands on - Swiss Medtech - ISO13485 - German/English

We are currently recruiting for a QA manager with a talent and passion to manage a team while themselves having responsibility for Quality System activities for this Medical Devices Manufacturer, located within a commute of Zurich, Switzerland. This is a replacement position with some flexibility in start date (ideally ASAP allowing overlap) but with a estimated duration of 12 months. Some home based work is also possible.

Reporting to the Senior Manager Quality Assurance, this position will provide leadership to 5-7 Quality Personnel working across multiple sites and covering expertise in Quality Systems Development and maintenance, Supplier Quality, Labelling, and CAPA. The ability to communicate in both German and English is essential

The hands on component will be to

  • Establish and maintain an effective quality system.
  • Conduct internal audits at regular intervals to ensure the quality system is in full compliance with applicable regulations and international standards.
  • Manage the supplier quality process
  • Ensure corrective and preventive actions are initiated to support continuous improvement, product quality and quality system compliance.
  • Ensure compliance and product quality with patient benefit in mind
  • Communicate and ensure awareness of Quality Policies and Objectives at all levels of the organization, and supplement via training as required
  • Inform Quality and Regulatory leadership, VP/GM, and business management with updates regarding compliance

Requirements:

Education: Degree (advanced degree preferred) in Quality Management or Engineering or relevant scientific discipline

Experience: 5+ years of hands on experience in the Medical Devices industry in a Quality &/or Regulatory function, and with experience with Class II/III medical devices, including clinical and commercial products.

Hands on experience implementing quality systems in a GMP environment, and direct experience with health authority inspections.

Knowledge: Global standards ( ISO 13485, ISO 9001, MDD, MDR, RDC, MHLW, CMDR, J-PAL), GMP, GCP, FDA, Quality System Regulation, Regulatory authority and notified body guidance

The role is key and comes at a important and challenging time for the company - interviews will be set up promptly, and with commitment to proceed independent of the current international (pandemic) situation.

For more information on this vacancy, please send your latest and greatest CV, together with scanned certifications of training and Arbeits Zeugnisse.

KEY WORDS: QMS, Quality Management System, Switzerland, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, French, German, ISO 13485, ISO 9001, GMP, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

NonStop Consulting
Oct 5, 2021

Contact info

NonStop Consulting
Andrew Boroky
p0w yw y- z7 )y( 07g
Not available