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
Support the Factory Focus teams to achieve current KPI of Quality, Delivery and Cost
Lead and support new products introduction process into manufacturing with active involvement in appropriate XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team
Pro-actively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites
Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
Ability to work collaborative across various QA functions in ResMed (Quality systems & Audit, design, supplier, manufacturing, and customer quality).
May perform Quality representative role for Operations projects and business activities that require broad quality expertise and support, eg: site moves / expansions, new process / business ventures, support / integration of acquired companies.
Develop Quality Agreements, Quality Plans, Project Based Risk Assessment
Perform or support internal / external / supplier audits
Partner with stakeholders and other functions to understand business & quality requirements and apply appropriate risk based decision making to achieve successful business and customer outcomes
Let’s talk about Qualifications and Experience
Required
Bachelor’s degree in Engineering or Science with 5 years’ experience in a regulated volume manufacturing industry.
Experience in Quality Systems / Manufacturing quality, risk management, requirements management and process validation
Self-starter, with the ability to work with minimal supervision and with a sense of urgency.
Good planning and organizational skills; ability to take own initiative and ownership.
Strong inter-personal, communication, and negotiation skills with the ability to interact positively with senior management and manage stakeholders.
Ability to work effectively with global teams, maintaining good relationships while influencing change
Preferred
Experience in Quality and/or Regulatory positions in medical device industry.
Experience in Quality System, Manufacturing Quality, process validation and risk management
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!
