Manager, Quality System
- Job Title
- Manager, Quality System
- Job ID
- Work From Home
- BOSTON, MA 02210
- Other Location
Founded in 2017, Activ Surgical is a first-of-its kind digital surgery company focused on improving surgical efficiency, accuracy, patient outcomes and accessibility for both endoscopic and robotically assisted procedures. Activ Surgical’s scalable and patent-protected surgical software platform technology is driven by computer vision, artificial intelligence, analytics and machine learning to enhance a surgeon’s intra-operative decision making and reduce unintended and preventable surgical complications.
Activ Surgical is looking for individuals who are interested in shaping the future of healthcare by improving patient outcomes, reducing healthcare costs, and addressing unintended surgical complications.
You’ll join a team where everyone – including you – is striving to constantly create innovative technology. We are an incredibly supportive team – we love to pitch in when problems arise and give great peer feedback to help each other grow. We are passionate about lots of things – artificial intelligence, machine learning, autonomous robotics and a great user experience--and we love sharing those passions with each other.
- Fortune 500 Health & Wellness Benefits
- Flexible vacation
Activ Surgical is introducing novel real-time intra-operative vision technology into minimally invasive surgery, meant to augment the traditional surgical video feed with complementary physiologic data.
We are actively seeking a Manager, Quality Systems to join company in Boston, MA.
- Overall responsibility for the maintenance and improvement of the Activ Surgical Quality Management System (QMS)
- Responsible for ensuring QMS is suitable for ISO 13485:2016 and 21 CFR 820 Quality System Requirements.
- Performs measurements of QMS effectiveness and prepares reports that are presented in the Management Review.
- Ensures all employees are fully trained and aware of all QMS requirements.
- Oversees the key areas of the QMS, such as Document Controls, Design Controls, Risk Management, Supplier Controls, Process Controls, Corrective Actions and Preventive Actions, etc.
- Works with Management Representative on QMS strategies relevant to the business’s global expansion plans.
- Collaborates with R&D, Operations, Regulatory Affairs, and other groups as needed to maintain QMS compliance.
- Outward facing responsibilities with regulators (FDA, Notified Bodies, etc.).
- Implementation and management of QMS tools (i.e. Arena).
- Minimum of 7 years of medical device QMS management experience
- Demonstrated track record of working with the FDA, notified bodies, and other regulatory bodies.
- Success in gaining/maintaining QMS certifications (i.e. ISO13485).
- Expert in all areas of a QMS.
- Management of multiple QMS processes at a time.
- Maintaining requirements for medical device QMS tools (i.e. Arena)