The company is looking to improve its quality systems and manufacturing processes to achieve current KPIs of Quality, Delivery, and Cost.
Requirements
- Experience / exposure in Quality Systems / Manufacturing quality, risk management, process validation
- Experience in quality system, manufacturing quality, process validation and risk management methodologies
- Experience in Quality and/or Regulatory positions in medical device industry
Responsibilities
- 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
- Pro-actively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team
- Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards
- Perform or support internal / external / supplier audits
- Provide quality / technical guidance through mentoring / training
- Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements
Other
- Bachelor’s degree in Engineering or Science with 3+ years’ experience in a regulated volume manufacturing industry
- Independent and proactive learner, with the ability to work under guidance of other senior team members
- Good planning and organizational skills; ability to take own initiative and ownership
- Build positive working relationships with internal and external customers
- 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
