Job Summary
The primary role of the Quality Assurance, Quality Systems 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.
The Quality Assurance - Quality Systems function supports:
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The management, maintenance, and optimization of the structure and integrity of the Global Quality Management Systems (QMS) to ensure ResMed’s products and our design and manufacturing operations comply with the regulatory requirements applicable to medical devices for the markets in which they are distributed.
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All aspects of the audit program to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Providing broad business technical support around QA systems and processes to the organization. Supports and implements significant quality projects across the business and also creates and improves quality and business processes.
Let’s talk about Responsibilities
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Support the management, maintenance, and optimization of the structure and integrity of the Global Quality Management Systems (QMS) to ensure compliance and alignment with applicable regulatory standards and business requirements.
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Support in the consultation and collaboration with Global Business Process owners to interpret, construct and apply robust processes into the Global QMS.
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Support the implementation of a Global QMS.
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Review, analyses, and implement opportunities for continual improvement of the Global QMS to meet business needs.
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Provide reports and metrics to management on the status of the Audit and Global QMS programs and provide an assessment of the possible resulting business impact.
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Build strong networks and work with teams in other ResMed locations to ensure that Quality Assurance systems/processes are in alignment Globally.
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Support the audit program (Internal, Supplier and External) to meet the requirements of the business and applicable external regulatory bodies.
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Manage the activities resulting from observations and non-conformances raised during internal and supplier audits and as part of CAPA investigations. Liaise with stakeholders and drive these findings to effective and timely closure.
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As required, support and represent ResMed in external audit situations through audit preparation, facilitation and acting as a direct auditee when required.
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Undertake other Quality Assurance Systems support and other ad hoc activities as required, including Audits and QMS support.
Let’s talk about Qualifications and Experience
Required
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Minimum 5 years applied professional quality assurance experience ideally including the medical or other regulated industry including ISO 13485 and/or 21 CFR Part 820 requirements
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Experience in Training and Quality System audits. Lead Auditor experience.
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Strong listening, verbal and written communication skills.
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Ability to identify linkages and dependencies between processes.
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Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
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Ability to successfully influence others to achieve outcomes.
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Agility to adapt and respond quickly while being resilient to overcome obstacles.
Preferred
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Bachelor’s degree in science or engineering.
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Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
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Experience in process improvement and value stream mapping.
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Formal Quality System Auditor training.
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Formal Training qualification or extensive training experience.
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Experience with Software as a Medical Device (SaMD)
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Acting as lead or experienced supporting auditor for internal, covering a range of relevant processes.
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. Employees have flexible time off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members. Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.
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 base range for this position is: $119,000.00 -$179,000.00 USD Annual.
For remote positions located outside of the US, pay will be determined based the candidate’s geographic work location, relevant qualifications, work experience, and skills.
Joining 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!
