As part of the Corrective and Preventive Action (CAPA) efforts, responsible for implementation of significant quality projects across the business, to create and improve quality and business processes. Work closely with quality professionals in engineering, Information Technology QA, and business processes to ensure delivery of high-quality business operations. Secure organizational commitment regarding priority, budget and resources for successful project implementation and work with IT Squad using Agile methodology to develop and maintain QA systems. Conduct projects with core team members from all company functions involved in assigned projects. Focus on development and implementation of strategic and operational objectives to achieve organizational mission. Implement organization strategies to ensure employees and resources have effective direction and management. Frequently interact with managers, supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and company. Often must lead cooperative effort among members of project team. This is an individual contributor position. Position does not have direct management or supervisory duties.

*Hybrid position*

Position offered by ResMed Motor Technologies, Inc.

Minimum Requirements        

• Bachelor’s degree or equivalent in Engineering Management, Operations or related field of study and
• 5 years of progressive experience in Project Management in Medical Device Manufacturing Quality and Regulatory Compliance. Employer will accept a
• Master’s degree or equivalent in Engineering Management, Operations or related field of study and
• 2 years of experience in Project Management in Medical Device Manufacturing Quality and Regulatory Compliance in lieu of a Bachelor’s degree or equivalent and 5 years of progressive experience. Employer will accept pre- or post-Master’s degree experience. All experience must be post-Bachelor’s degree.

Certification requirement: Project Management Professional (PMP)

Applicants must have demonstrated experience with the following:

• 5 years (2 years with Master’s) of experience in Manufacturing Quality (Lean or LSS) or Total Quality Management;
• Quality Management System concepts pertaining to medical device manufacturing;
• working with standards and regulations related to medical devices (including ISO13485, MDR, CAPA and 21 CFR 820); and
• Jira, Confluence, and Objective, or equivalent software.

Any and all experience may be gained concurrently.

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 accrue three weeks Paid Time Off (PTO) in their first year of employment, 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.  

Base Pay Range for this position: $137,114 - $174,000 per year.

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!