Senior Manager - Product Quality Assurance (Global Distribution)

ON SITE

The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. Key deliverables include creating and building relationships with medical device regulatory in every country. Ensure timely registration to meet business needs. Also, responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. Capability and process development for compliance and Continuous improvement. Global responsibility for QMS alignment across global quality systems. Maintenance and security of documentation system and record keeping.

Let’s talk about Responsibilities 

• Develop and maintain strong relationships with key stakeholders and customers. 
• Drive a strong culture of Quality through continuous improvement and other best practice Quality Management strategies across both direct and indirect teams. 
• Establish and ensure quality metrics are aligned with ResMed’s objectives and comply with best industry standards and practices.  
• Optimize team structure and resources to achieve optimal outcomes for ResMed’s quality, delivery and cost targets across its operations and businesses. 
• Develop a self-empowered and capable global team, with strong leaders and team members who collaborate without borders, learn from each other and work as one unified team in supporting the business.  Achieve this through goal setting, mentoring, feedback and other proactive talent development activities.  
• Ensure the implementation of various management systems within area of responsibility (including health & safety, quality & environmental) and monitor the performance of direct reports against requirements. 
• Maintain knowledge of ResMed’s Quality Management System (QMS) ensuring compliance with GMP, regulatory requirements and other business systems across areas of responsibility. Review for opportunities that arise for the continual improvement of the QMS. 
• Provide technical leadership, support and guidance to team – upholding relevant technical and quality standards through review activities. 
• Proactively drive better data analytics to support organizational need for better/early insights on data signals that affect Quality and for continuous improvement opportunities. 
• Act as Site Management Representative (as required) and as the key contact

• Strong relationship building, influencing and conflict management skills 
• Ability to identify, evaluate and act on existing and emerging Quality issues with urgency. 
• Excellent written, oral communication and negotiating skills. 
• Strong multitasking skills with the ability to prioritize to the business needs 
• Problem solving methods and tools as well as quality process knowledge, including statistics. Examples include A3, 8D, KT Problem Solving, DMAIC etc. 
• Present and report information clearly to various levels throughout the organization (Junior to Senior levels, including senior leadership VP/C-suite levels) 
• Ability to develop, motivate and keep team members engaged. 

Let’s talk about Qualifications and Experience 

Required: 

• Tertiary qualifications in Logistics/Engineering/Science or other related discipline  
• 10+ years’ experience in a Logistics/Distribution Quality Assurance environment 
• 5+ years' experience in leading / managing teams of Quality Assurance professionals 
• Experience working with Global team members across US, Europe and APAC 
• Experience in change management with respect to organizational and business process changes. 
• Knowledgeable with ISO 13485 and 21 CFR 820, Auditing and Inspection methodologies and techniques applicable Industry and International Standards 
• Focuses on the development and implementation of strategic and operational objectives that help achieve organiz