Hero / Hero Health (201-500 Employees, 51% 2 Yr Employee Growth Rate)
At Hero, we're on a mission to take the hassle out of taking meds for patients and caregivers with the first end-to-end medication management service that stores, sorts, dispenses, tracks, and refills even the most complex regimens.
We hope you’ll join us in improving the lives of millions of patients and caregivers across the country! With remote-first roles in the U.S. and a vibrant office culture in other markets, our roles allow you to bring your whole, authentic self to work to help us solve this complex health issue.
The Quality Assurance Manager role is responsible for developing and maintaining compliance of Hero’s Quality Management System (QMS) to ensure the delivery of safe and effective medical device products.
- Management of the QMS and Quality Assurance team, to ensure compliance with all relevant standards and regulatory requirements
- Assist the QMS Management Representative
- Work in conjunction with Regulatory Affairs to ensure compliance with applicable regulations
- Ensure appropriate QMS processes are maintained according to applicable standards and regulations
- Continual evaluation of developed procedures and specifications for appropriateness, adequate performance, and continual improvement, including those used by suppliers under contract to the manufacturer.
- Manage and ensure internal Quality System, Supplier, and third-party audits and inspections are completed, and any required responses are addressed appropriately and in a timely manner
- Identify and assist in the resolution of potential or existing quality issues
- Provide quality support to engineering, development, and manufacturing including process validation, design history records, and quality improvement initiatives
- Work with relevant technical experts to ensure that Corrective and Preventive Actions associated with Quality System-related activities are addressed and implemented appropriately
- Foster and maintain a workplace culture respectful and supportive of individual differences
- On-site visits will be required for vendor audits and audits by regulatory authorities, which will be less than 15% of the time.
- Bachelor’s degree in Life Sciences or Engineering or equivalent experience
- 5 years of experience within Quality Systems, Quality Assurance, or Regulatory field(s)
- Working knowledge of ISO 13485, FDA QMS, and other applicable standards
- Experience working in a medical device regulated industry, preferably with devices including software and electronic systems
- Working knowledge of multiple software applications (office or business software);
- Experience with quality management system software preferred
- Working knowledge of QMS concepts and tools
HERO is proud to be an equal opportunity workplace. We value diversity and always treat all employees and job applicants based on merit, qualifications, personality and talent. We do not discriminate on the basis of race, religion, ancestry, color, national origin, gender, sexual orientation, gender identity, age, citizenship, marital status, veteran status, or disability status. Click here to view Federal Labor Law posters.