Support the Factory Focus teams to achieve current KPI of Quality, Delivery and Cost.
Participate 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 guidance through mentoring / training.
Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards.
Build positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growth.
Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements and provide coaching and guidance to PFT on an ongoing basis.
Perform or support internal / external / supplier audits.
Let's talk about Qualifications and Experience Required Bachelor's degree in Engineering or Science with 3 years' experience in a regulated volume manufacturing industry.Experience / exposure in Quality Systems / Manufacturing quality, risk management, process validation.Independent and proactive learner, with the ability to work under guidance of other senior team members.Good planning and organisational skills; ability to take own initiative and ownership.Preferred Experience in Quality and/or Regulatory positions in medical device industry.Experience in quality system, manufacturing quality, process validation and risk management methodologies.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!
At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease and lower costs for consumers and healthcare systems in more than 140 countries. To learn more, visit ResMed.com and follow @ResMed.
ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
(US/Canada only) ResMed is an equal opportunity/affirmative action employer. ResMed is an E-Verify Employer. ResMed is a smoke-free workplace.
We are a 2024 Circle Back Initiative Employer – we commit to respond to every applicant!
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