08. November 2023

New opportunity – Quality Manager Medical Devices 60-80%

We are currently looking for a

Quality Manager Medical Devices (60-80%) 

to join our team.

In this position

• Are one of the key players for the optimization of our modular certified eQMS, covering active devices, software, non-active devices and in-vitro diagnostics and various geographies
• Are the subject matter expert (SME) for Change Control, Complaints, Non-Conformities and CAPAs and you will be in charge of the daily business management for these processes and all related activities. As SME you will ensure the continuous improvement of the processes and will participate in meetings with customers regarding changes and other pending activities.
• Are involved in final product release and product quality management.
• You are a key player in external (notified body, authority, customer) audit preparation and participate in external audits.
• You are involved in performing internal and supplier audits in accordance with the annual audit program. You are involved in supplier quality related tasks such as supplier selection, review and monitoring.
• You are a key player in the setting up and training of new eQMS customers and assist them during their path to certification.
• You assist in other quality management activities such as Post-Market Surveillance reporting, Computer System Validation, employee training and are an eQMS administrator.

You

• Have at least 3 years of professional experience in quality management and/or regulatory affairs from the medical device industry
• Knowledge of ISO 13485, MDR, IVDR, FDA and the certification processes for medical devices in Europe and the USA; knowledge of other markets (MDSAP countries) is a plus
• Are passionate about process optimizations and lean management.
• Are passionate about digitalization
• Have a customer focused approach to coordinate and supervise stakeholders to deliver a high-quality service
• Have a pro-active attitude and willingness to bring in ideas and suggestions to support continuous improvement
• Have excellent communication and interpersonal skills, ability to gain consensus on key quality decisions, and you value teamwork and find it enriching
• Have excellent knowledge of English, written and spoken, and good conversational skills in German

 We offer

• A new challenge! We have a broad spectrum of products – from software products to active and non-active devices, as well as IVD products – and customers, making this a challenging and fun position!
• The possibility of working in a motivated team with a common goal – accelerating innovation in the medical device industry.
• Flexibility – our offices are located in the center of Olten only minutes by foot from the train station; partially working from home is possible.
• The ability to actively shape and further develop the company with us to reach our common goal.
• Personal development opportunities in a growing company.

Do you share our vision to facilitate and accelerate medical device product innovation by offering a plug-and-play QMS and outsourced legal manufacturing? If the answer is “YES!” we are looking forward to getting to know you.

Please send your full application (CV, motivational letter, work certificates & diplomas) to Anne-Marie Joller at hr(at)effectummedical.com 

Kindly indicate your salary expectations and your availability/notice period in your application.

Please note that we only accept direct applications (no recruitment companies) and only complete applications will be considered.

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