Senior Quality Assurance Specialist

About the role:

You will be working in a team that is passionate about innovation in the (connected) healthcare industry and the products we develop. As a Senior Quality Assurance Specialist, you will be responsible for the Quality strategy and governance, ensuring the development and compliance of the medical products we help design and develop at Nipro. This role includes Quality Assurance, governance and compliance, project management, QMS maintenance, and audit support for our medical product portfolio.

You will report to the VP RAQACA with dotted line to the VP R&D EMEA

What you’ll do:

Quality Assurance (60%)

• Ensure product compliance with CE, ISO13485, MDR, product standards, and environmental requirements.
• Maintain accurate and detailed records of quality assurance activities.
• Identify and document quality issues and recommend solutions.
• Train and support staff on quality assurance processes and best practices.
• Conduct regular inspections and quality tests.
• Develop and implement risk mitigation strategies.

Project Management (15%)

• Collaborate with other departments to ensure quality standards are met.
• Closely cooperate with Nipro Corporate Japan, R&D Japan, and suppliers of products and parts.

Governance & Compliance (10%)

• Develop and implement quality policies and procedures.
• Monitor and report on quality performance.

QMS Maintenance and Audit Support (15%)

• Conduct regular risk assessments and audits.
• Prepare and support internal and external audits for ISO 13485, MDR, and ISO 14001.
• Ensure timely resolution of audit findings and recommendations.
• Maintain documentation and evidence for audit purposes.

What you’ll need:

• Experience in Quality Assurance, particularly in the R&D medical device industry
• Knowledge of CE, ISO13485, MDR, and other relevant standards.
• Strong project management skills.
• Excellent communication and collaboration skills.
• Ability to train and coach staff on quality assurance processes.
• Detail-oriented with strong problem-solving abilities.

Why you should apply:

• Join a team that is at the forefront of innovation in the healthcare industry.
• Work in a collaborative environment with cross-functional teams.
• Contribute to the development of products that meet the highest standards of quality, safety, and regulatory compliance.
• Be part of a company that values quality and continuous improvement.
• Work in the EMEA HQ of an international company, with 30 different nationalities
• Home working is offered 2 days a week