Manager, Quality Assurance (Design Controls)

Company: ResMed Inc
Location: San Diego
Posted on: September 18, 2023

Job Description:

Manager, Quality Assurance (Design Controls) page is loaded Manager, Quality Assurance (Design Controls) Apply locations San Diego, CA, United States time type Full time posted on Posted Yesterday job requisition id JR_026696 Job Summary This role will provide supportive and inspirational leadership of the Quality Assurance team supporting design controls/product development (PD) for DHT (Digital Health Technology) products. A key aspect of this role is influencing development teams and processes through strategic engagement and individual hands-on contribution. Let's talk about the role

• People management and leadership of direct reports. Support development and growth opportunities for the team, with regular feedback to ensure team members continue to develop and grow their capability, and be the best that they can.
• Work with the QA PD/DHT team to develop team culture and to enable consistent approach and support across PD/DHT teams, e.g. in execution of QA plans, review and approval of deliverables, escalation of risks.
• Provide support to team members to analyse potential quality risks. Identify and support or lead resolution of quality risks that impact product development, with effective escalation, collaboration and communication.
• Support the capability of QA, PD/DHT and cross-functional representatives by awareness of current and changing industry requirements/guidance/best practice in the area of product development. Disseminate information and provide appropriate informal and formal training.
• Partner with cross functional teams and leadership to champion product quality and drive quality considerations into key decisions.
• Proactively source inputs from the business (e.g.QA, cross-functional teams, leadership) to inform strategy and identify improvement areas, and then lead implementation of associated changes.
• Manage delegation and assignment of workload within the team and participate in resource planning for current and future PD/DHT projects.
• For assigned product/s, achieve the above both at an overall level as well as through hands on individual contribution as primary QA representative on at least one project's cross functional team.
• Ensure implementation and compliance to ResMed health and safety management systems within the areas of responsibility, and monitor the health and safety performance of direct reports. Let's talk about you
  • Degree in Engineering, Computer Science, Science or other tertiary qualifications deemed appropriate for this position.
  • Minimum of 5 years' relevant experience or equivalent demonstrated ability in a product development environment including software products.
  • Demonstrated ability to take initiative and work with minimal supervision to achieve role responsibilities effectively.
  • Experience in global requirements for design controls and quality systems for medical device development, e.g ISO13485, 21 CFR Part 820, EU MDR.
  • Experience with IEC62304, IEC82304 and different software development methodologies, e.g. Agile, DevOps.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 fifteen days 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. -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:$112,000.00 - $168,000.00For remote positions located outside of the US, pay will be determined based the candidate's geographic work location, relevant qualifications, work experience, and skills.#LI-LP1#Hybrid 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! Similar Jobs (1) Manager, Regulatory Affairs locations San Diego, CA, United States time type Full time posted on Posted 30+ Days Ago About Us 0:00 -/ - 1:51 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 2023 Circle Back Initiative Employer - we commit to respond to every applicant!

Keywords: ResMed Inc, San Diego , Manager, Quality Assurance (Design Controls), Executive , San Diego, California