329 days ago on sire-search.com

Senior Project Manager QARA

SIRE Life Sciences

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Senior Project Manager QARA

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!


Our client is a professional Medical Devices organization, based in Zürich Switzerland.

They company is a mid-sized medical devices company, exporting their products all over the world. They are both ISO 13485, CE and FDA certified. About half of their products are being exported to the United States.


In this role, you will oversee all the important quality and regulatory projects within the company. Flexibility and a strong sense of understanding urgency are required. In this role, you will communicate with all offices of the company worldwide, to make sure the high standards of quality are being maintained.

You will be responsible for the research into quality issues all over the world. You will be responsible for all CAPA management for the high importance quality and regulatory issues.


- Direct oversight of all Suppliers and supplier-related issues
- Managing cross functional and cross geographical teams worldwide
- Representing of the company during both Notified Body and ISO audits
- Make sure all quality operations programs make sure products are compliant with the standards of the company
- Lean Six Sigma approach to support business continuity

- Training of employees, providing guidance to team members to let them develop to reach their full potential
- Decisive vote in starting of projects / programs into quality related issues
- Lead important projects related to change management and business process deployment
- Reviewing and Improving device design where needed
- Strategic oversight over all quality related projects


- 10+ years of experience in Quality Assurance
- 10+ years of experience in the Medical Devices industry
- 5+ years of FDA experience
- 10+ years of ISO 13485 knowledge and involvement

- Lean Six Sigma Yellow or Green Belt
- Lead Auditor for ISO 9001 and/or ISO 13485

- Fluent in German and English

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.