QMS specialist - Epalinges, Schweiz - Novostia

Beschreibung

Novostia is a clinical stage company founded in April 2017, in Switzerland, that is developing a breakthrough heart valve prosthesis offering superior benefits and quality of life to young adults and elderly people suffering from heart valve disease.

QMS specialist

The QA Specialist focusses on the development, implementation, and continuous improvement of the quality system in compliance with ISO She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements.

Responsibilities and Duties

Reporting to the Quality, Regulatory and Clinical Affairs Manager, your principal duties and responsibilities will be to:

• Ensure that Quality System requirements are met in order to achieve and maintain compliance with applicable regulations.
• Lead the preparation and execution of external and internal audits.
• Lead the Management Review preparation and execution (KPIs review, trends analysis, ...)
• Manage timelines for quality system planning.
• Participate to CAPA and NCR investigations.
• Lead Documentation Management (release, storage, archiving).
• Ensure regulatory watch and inform colleagues on regulatory requirements and the impact of new and revised regulations on products and processes.
• Participate in Technical Documentation development and maintenance.
• Support compilation of relevant clinical submission
• Support labeling implementation.
• Other duties as assigned.

Challenges ahead:

• ISO 13485 certification on going.
• Electronic QMS system to assess then, potentially, to implement.

The expected profile

• Bachelor's or Master's degree in life sciences, biomedical, mechanical, or microengineering, or a related field of study, or proven experience in the healthcare and life sciences industry.
• Min. 3 years' experience as a Quality Management System Specialist for medical devices. First experience in Regulatory Affairs an asset.
• Consistent knowledge of Medical Device Industry standards and regulations (ISO 13485, ISO 14971, EU MDR 2017/745).
• Rigor, methodical approach, detail-oriented, self-sufficient with the ability to work as part of a team that must be motivated to implement and comply with quality guidelines, a strong sense of responsibility.
• High-quality writing in English and French. Sense of aesthetics for the elaboration of Word, Excel and PowerPoint documents.
• Communication skills for oral presentations.
• French or English mother tongue, other language level C1 (German an advantage).
• Ability and willingness to work in start-up environment.

Additional information

• Strong development opportunities.
• Starting date: ASAP
• Location: Lausanne (Epalinges).
• Activity rate: %.
• Applicant must hold a valid Work Permit in Switzerland.