We at Stratasys are passionate believers in the value and power of 3D printing, and in the change it can bring to design, innovation and manufacturing.
The solutions we create are used by over 20,000 enterprises worldwide, and are rapidly changing the way products are imagined, designed, marketed, produced, supplied and sold. We are literally shaping the world that surrounds us – from the products and services in our lives and homes, to our health and quality of life, our transport, security and economies, to how we teach, research and even learn.
Stratasys is the largest 3D printing solutions’ company in the world – a company at the forefront of 3D printing innovation for more than 25 years
QA/RA Specialist will be responsible for managing quality systems development and maintenance and coordinating healthcare related regulatory activities for the company.
As this is the company’s first Quality and Regulatory full-time position, a broad, working knowledge of key aspects of both disciplines will be required.
The immediate need and focus will be in project management, quality Systems, with the regulatory responsibilities increasing over time.
Strong leadership and team skills will be important to guiding and aligning the internal team and external consultants.
rovide significant guidance as well as hands on support if needed, in the development of new documents, procedures, and changes to existing\new procedures, processes, plans, and other quality system documentation. Do so in closely with external advisors.
Support the creation of regulatory submissions (510K, PMA, technical files)
Coordinating filing of amendments to regulatory agencies.
Instituting document control paradigms for regulatory function
Bachelor’s degree in a scientific discipline (e.g., Biology, Biomedical Engineering)
5+ years industry experience with a medical device company.
Broad understanding of key elements of Quality Systems.
Working knowledge of medical device design control.
Strong knowledge of FDA\EU regulations
Must be aware of ISO 13485, ISO 14971 Risk Management for Medical Devices.
Strong organizational and communication skills, both written and presentation.
Able to work with a diverse group of individuals and styles, internally (employees) and externally. (consultants)
Respect and adherence to timelines
Excited for start-up culture: adaptability, occasional ambiguity, limited resources, willingness to do what is necessary to get the job done.
Self-motivated, willing to learn.