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 contactStrong 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 organizational mission. Implements organization strategies through the effective direction and management of employees and resources.Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.Manages professional employees and exercises full management authority, including performance reviews, pay decisions, recruitment, discipline, termination and other personnel actions.Travel up to 10%.
Let’s talk about Qualifications and Experience
We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
Subject to the absolute discretion of the company, this role may be eligible for an annual cash bonus payment based on company, business unit, and/or individual performance.
Subject to the absolute discretion of the company, this role may be eligible to receive stock equity based on company, business unit, and/or individual performance.
At ResMed, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this position is:
Total Base Pay Range
145,000.00 - 181,000.00 - 217,000.00 USD AnnualJoining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!