The main mission of the Quality Regulatory and Safety department is to create and support a Quality culture across the company by driving compliance activities through product life cycle. This includes driving the Quality and Compliance activities for the Quality Management System (QMS) implementation, quality improvement cross all sites/regions.
Duties and Responsibilities:
As Quality Assurance Manager, your responsibilities will be to:
- Manage and maintain the Quality Management System and implementation of applicable standards and regulations cross businesses and regions
- Responsible for engaging strong interdepartmental and cross-functional/organizational relationships to drive Quality System Requirements
- Maintain compliance of the Quality Management System Develop and Monitor quality metric to assess the Quality Management implementation and alert on deviations
- Ensure that GMP/Quality Standards/Procedure/Methods/Guidelines are applied
- Continuously review and put strategies in place to improve existing processes and champion implementation of new initiatives across the company quality function to ensure consistency, compliance and best practice
- Establish indicators with company departments
- Work on GxP to support company activities
- Support the global risk management program
Profile You have:
- Proven experience in a Quality Assurance environment
- Knowledge of ISO 900 and ISO 13485
- Knowledge of GxP to support company activities
- Knowledge in risk management, ISO14971 is an asset
- A good knowledge of Microsoft Office tools, such as Word, Excel, PowerPoint
And you are:
- You are able to organize your work and to take initiatives
- You are rigorous and consistent in all daily document control activities
- You are a driven proactive and hands-on-person
- You are able to influence and convince in a softly way
- You are a custom oriented team player with very good communication skills
- You speak both, English and French.
- Our company is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy.
- The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including company’s leading fully integrated radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.
- Employing more than 1,500 people worldwide, Our company currently has installed systems across Europe and the US and is expanding into emerging markets.
- The Company is focused on providing solutions in the fight against cancer.
- Our company offers you the opportunity to realize great achievements in the fight against cancer.
- Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !
- If you are stimulated by multicultural challenges and willing to travel, we offer you the opportunity to join a team of more than 35 nationalities working on more than 40 different sites on 3 continents.
- Our company offers you a competitive performance based compensation package and a flexible work environment.
- You have real possibilities to evolve within company's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp
- As an Equal Opportunity Employer our company is committed to a diverse workforce.