Design and Development Quality Manager

Design and Development Quality Manager at Aroa Biosurgery Limited in Whitford, Manukau

Role Overview

Aroa Biosurgery Limited is seeking a Design and Development Quality Manager to join our team. This role will be pivotal in ensuring the quality of our innovative wound care products from design through development stages. Reporting directly to the Head of R&D, you will collaborate with cross-functional teams to ensure compliance with regulatory standards and industry best practices.

Core Duties

• Develop and maintain quality management systems that comply with international regulations (e.g., ISO 13485).
• Lead the design, development, testing, and validation of new products to ensure they meet regulatory requirements.
• Conduct risk assessments and manage quality assurance processes throughout product lifecycle.
• Collaborate with cross-functional teams including R&D, manufacturing, and marketing to align on quality goals and objectives.

What You Bring

• A degree in Biomedical Engineering or related field; an advanced degree is preferred.
• Minimum 5 years of experience in a design and development role, with at least 3 years in quality management.
• Proven track record in developing and implementing quality management systems for medical devices.
• Strong understanding of regulatory requirements (e.g., FDA, CE marking).
• Excellent leadership skills to manage cross-functional teams effectively.

Working at Aroa Biosurgery Limited

Aroa Biosurgery Limited is a New Zealand-based company that develops and manufactures innovative wound care products. We pride ourselves on our commitment to quality, innovation, and making a positive impact in the lives of millions around the world. Our team culture values passion, creativity, and collaboration.

Apply Today

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