The Company

At Anteris Technologies, we are committed to discovering, developing, and delivering innovative solutions for significant challenges facing heart patients and their physicians. We're currently focused on developing a novel, first-in-class biomimetic transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis. The DurAVR™ TAVR system is currently in the clinical trial phase of development.

DurAVR™ THV is a novel first-in-class biomimetic valve made from a single piece of native-shaped tissue. It’s designed to mimic the performance of a pre-disease human aortic valve. Early data from the company’s First-in-Human clinical study show excellent hemodynamic performance at 12 months.

ADAPT® is Anteris’ patented anti-calcification tissue technology. ADAPT® tissue has been used clinically for over 10 years and distributed for use in over 50,000 patients worldwide.

The balloon expandable ComASUR™ Delivery System provides controlled deployment and accurate placement of the DurAVR™ THV valve, designed to achieve precise alignment with the heart’s native commissures to achieve ideal valve positioning.

The team has global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia. Help us build a team that will shape the future of TAVR.

Purpose of the Position

As the Director of Quality Engineering at Anteris Technologies, you play a crucial role in our mission to transform cardiac care. Reporting to the VP Quality, you will be responsible for leading the quality assurance and quality control functions, with an emphasis on ensuring technical aspects meet the compliance requirements of the medical device industry. This role involves ensuring products meet stringent regulatory standards, improving quality systems, and implementing technical solutions to enhance product reliability and performance. At Anteris, you will be a part of a global team of quality professionals who are focused on driving continuous improvement to ensure the highest levels of product quality, compliance, and patient safety.

Key Responsibilities

• Quality Strategy: Collaborate in the development and implementation of a comprehensive product quality strategy that aligns with the company's mission and objectives, ensuring continuous improvement in product quality and quality system compliance.
• Global Partnership: Work with the Anteris site in Perth, Australia as a supplier of tissue to fostering a culture of continuous improvement, accountability, collaboration, and innovation.
• Quality Leadership: Work collaboratively with other technical leaders to ensure a culture of quality and compliance becomes part of the DNA of all functional teams.
• Regulatory Compliance: Stay abreast of all relevant regulations and standards (e.g., FDA, ISO, CE) and ensure that all quality processes and systems meet or exceed these requirements.
• Quality Systems: Contribute to the maturing and robustness of the quality management system, including the use of an eQMS.
• Quality Metrics: Develop and monitor key quality performance metrics, utilizing data-driven insights to drive process and product improvements.
• Supplier Quality Management: Collaborate with supply chain and procurement teams to establish and maintain supplier quality standards and ensure the integrity of the supply chain.
• Risk Management: Implement robust risk management practices throughout the product lifecycle and quality system, identifying potential risks and mitigating them effectively.
• Audits and Inspections: Oversee supplier quality audits and inspections, ensuring compliance with all relevant regulations and standards.
• Continuous Improvement: Champion a culture of continuous improvement by promoting Lean and Six Sigma methodologies, fostering a proactive approach to problem-solving.
• Design Quality: Collaborate closely with R&D and engineering teams to drive design and process improvements that enhance product quality and performance.
• Operations Quality: Collaborate closely with Operations to ensure product and process meet defined quality requirements. Ensure all finished goods meet product requirements before shipment.
• Communication: Effectively communicate quality goals, progress, and challenges to senior leadership and cross-functional teams.
• Budget Management: Manage the quality engineering department's budget efficiently, allocating resources to achieve quality objectives.

The Candidate

Experience and Professional Qualifications

• Bachelor's degree in a relevant field; an advanced degree is preferred.
• Minimum of 10 years of progressive quality management experience in the medical device industry; implantable class III preferred.
• Proven track record of successful leadership in a global quality organization.
• Thorough understanding of regulatory requirements and quality standards relevant to medical devices (e.g., FDA QSR, ISO 13485, ISO 14971, MDR).
• Experience with quality management software, preferably Grand Avenue Quality Management Software.
• A continuous mindset approach, with a track record for understanding changing methodologies that will yield continuous improvement.
• Strong analytical and problem-solving skills. Lean and/ or Six Sigma experience a plus.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work collaboratively in a cross-functional environment.
• Certified Quality Manager (e.g., ASQ CQM/OE) certification is a plus.

Note: This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of skills, efforts, duties, responsibilities, or working conditions associated with it. Tasks and responsibilities may be subject to change based on business needs and at the discretion of management.

Full Compensation Info: $200,000 median base salary with 25% bonus

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