Miroculus is looking for a motivated, hands-on, and analytical Senior Manager, Development and Manufacturing Quality Engineering to drive high quality standards across development and implementation of our Next Generation Sequencing Sample Prep product strategy.
Miroculus has re-imagined the paradigm of laboratory testing, so that high quality science can be practiced anywhere in the world.
Through the use of their proprietary digital microfluidics technology Miroculus can automate manually intensive experimental workflows on to a low-cost cartridge, simplifying the preparatory workflow that currently relies on either manual execution or large and expensive robotic instrumentation. Making it reproducible and more affordable than ever before.
As the Senior Manager, Development and Manufacturing Quality Engineering, this individual will be responsible for providing effective Quality Engineering leadership, implementation guidance and oversight of the Design Control Process and Risk Management activities for development projects, Vendor and Manufacturer Qualification, Incoming Materials and Final Acceptance Testing definition.
This position reports to the Director of Systems Development.
Manage the Quality Engineering (HW & SW), Doc Control, and Supplier Quality aspects of ongoing and new development projects.
Ensure awareness and compliance to the corporate Quality Management System (QMS) and international quality standards, including FDA QSR and ISO 13485 requirements.
Responsible for generating and delivering documentation for life cycle management and/or registration of products from RUO through to medical device filings for FDA and CE
Provide guidance to assure the implementation of quality systems affecting all aspects of development and implementation process, including process control, process improvement, testing and inspection.
Work closely with R&D functional groups to ensure compliance to applicable standards (external and internal) such as IEC 60601, 61010, 62304, 62366-1, CE-IVDR, RoHS, REACH, WEEE.
Ensure the Customer Input Requirements are appropriately captured for best-in-class performance of new products against predicate devices, competitors and market expectations. Team provides design inputs as necessary.
Accountable for reviewing & ensuring the test strategy, protocols and their execution, in the development and manufacturing cycle, meet quality system and regulatory submission requirements.
Executive / senior industry position
San Francisco , United States