Quality Assurance Specialist

We are seeking a highly motivated Medical Device Quality Assurance specialist to join our team.

What will you do?

In this role, 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.

Key Activities:

• Develop, implement and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001 and ISO 27001 requirements;
• Ensure that complaint handling processes are implemented and followed, and that complaint investigation reports are properly documented and closed in a timely manner;
• Conduct internal audits to support compliance with quality systems and regulatory requirements;
• Take a role to identify root causes and implement corrective actions;
• Participate in supplier audits and follow the Supplier Corrective Action Requests;
• Support internal audits and take a role in the CAPA and non-conformance processes.

What do you bring?

• Bachelor’s degree in a relevant field (i.e. engineering, science, quality management);
• 2-3 years of experience in medical device quality assurance;
• Strong understanding quality systems requirements;
• Strong knowledge about the ISO 13485 and ISO 9001;
• Experience with medical device technical file preparation;
• 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;
• Strong analytical and problem-solving skills with the ability to identify root causes and implement corrective actions;
• Excellent organizational and time management skills, with the ability to manage multiple projects and priorities;

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.
Canon Medical Systems is a world leading healthcare provider. Our ‘Made for Life’ philosophy reflects our ongoing commitment to humanity. We provide medical professionals with solutions that support their efforts in contributing to the health and wellbeing of patients worldwide.

At Canon Medical Systems you will get the opportunity to make a difference in people’s lives while working with us. You’ll get the support and encouragement you need to grow, from people who share your ambition.

Our headquarters are currently located in Zoetermeer. Canon Medical Systems Europe plans to relocate to Amstelveen in mid-2023.

More information or apply?
For questions and to apply, please contact Christy Billar, Talent Acquisition Business Partner, at cmse.recruitment@eu.medical.canon. We look forward to receiving your application.