• Provide leadership and focus on the development and management of ResMed’s quality management system, critical business function skills and competencies by working cross functionally with product development, quality, regulatory, manufacturing, production, supply chain and support functions. • Responsible for the management, direction and implementation of ResMed’s quality management system, quality process training and development activities across the business. • Responsible for the design, implementation and effectiveness of a scalable quality process training system that is integrated with the quality system. • Develop forward looking plans for skills mix and capability requirements in support of ResMed’s global strategic goals. • Lead continuous improvement efforts for quality training through evaluation of trends in key performance indicators, audit and stakeholder feedback and corrective / preventative actions. • Develop and implement plan for the establishment of ResMed’s ‘One QMS’ – global QMS across all sites.

•Manage the Quality Systems for Clinical Genomics subsidiaries (Enterix Pty. Ltd. (Legal Manufacturer) and Enterix Australia Pty. Ltd. (Pathology Laboratory) ensuring compliance to ISO 13485, ISO 15189 21 CFR 820, NPAAC Guidelines, FDA, TGA and Medsafe. •Drive the implementation and maintenance of an innovative Global QMS and infrastructure that is compliant, effective, efficient and agile. •Oversee the comprehensive global regulatory process, incl. integration into product design, validation, project management, regulatory submission and approval & meeting design and customer specifications. •Establish quality compliance monitoring programs (incl. Management Review, quality metrics and global quality compliance program comprising of both internal and supplier audits) oversee and drive execution of site and supplier corrective actions to ensure compliance. •Transform Qual. & Reg Systems and continuous improvement of the QMS for agility and scalability. •Establish annual QA & RA Planning and Objectives while ensuring an effective monitoring and escalation process.•Participate in product development – assisting in preparing reg strategy, review Design History File deliverables for substantiation of reg submissions and compliance, participate in risk analysis and design reviews, review of clinical trial master files & other associated trial deliverables.•Oversee and manage facility inspections and audits on a global basis & related agency communication. Drive and leverage agency collaboration for risk mgmt and continuous improvement.•Grow, develop and manage the QA & QC teams and local RA resources to interface and support all reg compliance rqts of the company. Modernize the corporate culture and cross-functional relationships with QA/RA toward one that’s collaborative and cohesive.•Act as Quality SME and provide training/consultation to internal and external customers on applicable regulatory requirements (proactively and reactively) and QMS in general.

• Develop and Lead the ETP Quality and Engineering Teams, the Quality Management System and Regulatory Compliance Programs.• Establish, implement and continually improve an effective quality management system (QMS) to ISO 9001 with a view to obtaining ISO 13485 including Management Review, Document Control, Product Realisation, Internal and Supplier Audits, Site Certifications and business wide QMS Training and Quality Communications, using input from CAPA activities (product and process) complaints and quality data analysis.• Formulate and drive appropriate strategies in response to our Customers’ existing and emerging compliance requirements (e.g. RoHS & REACH).• Commit to continuous improvement by developing and setting the direction and priorities for the team. In particular develop process improvement program and initiatives e.g. using six-sigma, lean initiatives and Management Review reporting to remove redundancy and increase QMS effectiveness.• Establish and implement meaningful and visible KPI’s that support the Quality Policy and Objectives.• Ensure the Quality strategy developed aligns with ETP Business Strategy

•Ensure that the release of high quality products from Manufacturing, comply with specifications and regulatory •Ensure all acceptance and product release activities are implemented and appropriate•Ensure appropriate process controls and monitoring are in place•Ensure material review board are conducted to ensure that non-conformances and CAPAs are timely in resolution and appropriately and thoroughly documented. •Produce regular status reports for non-conformances, audit findings, and process monitoring activities.•Escalate and make urgent recommendations to the Head of Quality where production should be stopped to contain or resolve product issues•Work with key stakeholders in NPI and D&D as the quality subject matter expert to ensure that quality processes and considerations are optimized for the successful design transfer of new manufacturing products or processes. •Participate in Change Review Board implementation and maintenance.•Lead Internal and Supplier Audits - plan, conduct and report.•Work with Client Group to resolve findings identified during internal and supplier audits•Develop and implement a regular and systematic education and training program for Group to ensure the group are competent in the execution of all quality operational processes and acceptance activities, and to ensure the Client Group are “audit ready” at any time. •Ensure data from process monitoring and acceptance activities is available and analyzed to make recommendations to Head of Quality for continuous improvement and prompt identification of potential quality issues.•Ensure the Quality Compliance Engineers are active in checking, identifying and ensuring all quality operational processes in Manufacturing are compliant to ISO 13485, EN ISO 13485, 21 CFR Part 820 and internal Cochlear requirements.•Oversee the modification of existing, or implement new, processes, to ensure compliance with applicable regulations or standards.

•Process owner for the CLN site NC Process – including supervision & Leadership of NC admins, system management and metrics reporting at all organizational levels (including Corporate) •Quality Incident process owner for the CLN site – managing CAPA actions related to customer complaints and nonconforming product escapes.•Engineering Essentials Project Mentor for Final Pack, Supply chain & Sterilization•Support new product Introduction, product adoption, Validation and Routine Processing – including regulatory assessments and launch activities •Identify, Drive and Implement Quality and Cost Saving Improvements •Monitor and maintain sterilization product quality & compliance to standards and goals•Support corporate and divisional Quality Goals and Objectives related to Compliance, Product Performance and Quality System Operational Excellence

•Support product Sterilization for the Ireland site’s 4 chamber, Ethylene Oxide Parametric Sterilization Process•Support of new product Introduction, product adoption, Validation and Routine Processing•Maintain sterilization key metrics; e.g. within goal for Sterile Load Failure Investigations •Annual Re qualification of site sterilizers and ancillary operations (e.g. Software Val, Re-commissioning and Equivalences)•Ensure compliance and regulatory requirements are met including gap analysis to the latest standards.