United States onlyThe Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. The position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.
Requirements
- Bachelor’s degree in a science, engineering discipline, or equivalent
- Minimum 10 years in medical device industry leading projects with a focus on process improvement and data analytics
- Proven ability to lead and manage cross-functional teams effectively communicate with all levels of management and drive effective change
- Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA
- Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits
- Experience writing, reviewing, and providing feedback on requests for additional information or audit responses
- Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations
- Experience working with, presenting, and communicating with executive leadership
- Experience with implementing tracking and monitoring tools
- Fluent in English language
Benefits
- Competitive salaries
- Annual bonus
- 401(k) with company match
- Comprehensive medical, dental, vision coverage
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center
PT, ES + 1 more
AU, CA + 6 more
JP and US only