Quality Engineering Manager
- Job Title
- Quality Engineering Manager
- Job ID
- 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
Senior Quality Engineer to perform the following critical tasks:
Work with Research and Development on Design Verification and Validation, providing
leadership and guidance on requirements development, testing, and reporting;
Work with R&D, Commercial, Clinical, and Operations on design changes;
Work with Operations and Contract Manufacturing on Process Controls and Manufacturing QA,
including IQ/OQ/PQ, AQL, NCMR and Rework, CAPA, and design and process changes;
Lead efforts for post-market investigations, measurement, and reporting;
Lead efforts for process measurement and reporting; and
Process lead for internal audits, supplier quality, and external audits.
Experience with design, development, design transfer, manufacturing, and post market quality
activities in a medical device setting;
Deep knowledge with ISO 13485, 21 CFR 820, 21 CFR 803, ISO 14975, IEC 60601;
Leading cross-functionally across QA/RA, R&D, Operations, Marketing, and Clinical;
Leading with vendors and regulatory bodies;
Developing and owning measurements of process and product, and reporting on these for
Management Review and other required reporting responsibilities;
Working with FDA, Notified Bodies, and other regulatory bodies, as necessary;
Cooperating with contract manufacturers and other suppliers in order to achieve highest levels of
quality and compliance; and
Leading efforts for continuous improvement.
Work Environment/ Traits
Small team with multiple, constantly changing responsibilities;
Very strong written and oral communication capabilities;
Travel to contract manufacturers and vendors, as needed;
Solid leader looking to build and improve on systems and processes;
Need to be a team player, willing to fill gaps as they are identified; and
Enthusiastic, independent, decisive, flexible.