Senior Quality Assurance Manager

Do you want to join a world leading healthcare provider and make a difference in people's lives? Do you have a strong knowledge of quality system requirements, ISO standards (ISO13485, ISO9001, ISO14001, ISO27001), great communications and management skills? Then apply now!

Our QARA department at Canon Medical Systems Europe (CMSE) is growing! We are looking for a highly motivated Medical Device Sr. Quality Assurance Manager to join our team.

What will you do?

In this role, you will report to the RA/QA Director, you will be responsible for ensuring the quality compliance of devices according to the applicable laws, regulations, standards, and guidance. You will be working closely with cross-functional teams to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.

• Develop and Maintain Harmonized Quality System in compliance with ISO 13485, ISO 9001, ISO 14001 and ISO 27001 requirements;
• Maintain the proper execution of audit activities for CMSE and Group Companies where applicable.
• Keep up to date with regard to developments in the sphere of quality control and advise about quality actions.
• Mentor and coach QA Manager and QA Specialist.
• Advises the employees of the Group Companies concerned about how they should organize the Quality Assurance Policy in the Group Companies.
• Guarantee Risk Management tasks are performed according to company’s expectation.
• Ensure that the process of internal and external, distributor and supplier audits are in place on a timely manner
• Support suppliers and dealers to ensure that their products and services meet quality standards and specifications.
• Responsible for creating and finalizing the CAPA and setting the CAPA policy

What do you bring?

• Bachelor’s degree in a relevant field (i.e. engineering, science, quality management).
• At least 6 years’ experience in medical device quality assurance.
• Strong understanding of quality control.
• Thorough understanding of ISO standards (ISO13485, ISO9001, ISO14001, ISO27001) and other relevant quality guidelines.
• Strong leadership skills and experience managing a team of quality professionals.
• Excellent English language skills both written and spoken, ideally you also speak and understand an additional EU language;
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment;
• Detailed-oriented with strong analytical skills and experience successfully leading quality initiatives and achieving results.
• Ability to take initiative and make decisions under pressure.
• Self-reliance with regard to the development of the Quality Assurance System and implementation of this system in the Quality Assurance Policy of the organization.
• Ensures that all quality assurance guidelines and standards are complied with.

What do we offer?

You will work in a professional team and in a challenging environment with many opportunities to expand your knowledge and experience. In addition, we offer you:

• a gross monthly salary appropriate to your knowledge and work experience;
• a 13th month and 8% vacation allowance;
• 32 vacation days and 5 scheduled days off;
• travel expenses / home office allowance.

About Canon Medical Systems Europe B.V.

If you want to apply please visit our LinkedIn Jobs page: Senior Quality Assurance Manager | Canon Medical Systems Europe | LinkedIn