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.
- Lead the development of supplier quality and incoming quality strategy and implement for new product development.
- Support the R&D and procurement groups in the development of raw material specifications and the requirements of supplier qualification.
- Supports Manufacturing in Process Validation and Control Planning & ensures implementation.
- Work closely with engineering and manufacturing to define and develop testing procedures and tools to ensure product design and production quality.
- Proactively champion investigation and resolution of quality issues
- Provide design-for-manufacturing and design-for-service feedback during the development process
- Maintains traceable list of design and tolerance issues throughout development and verifies corrective actions through design phases
- Provides feedback to bill of materials (BOM) and leadership in coordination of BOM changes throughout the supply chain and the requirements of supplier qualification.
- Defines and leads activities for transfer of new products into manufacturing.
- Contributes to process FMEA development and risk management strategy.
- Develops process control points to minimize risk to product.
- Participates in the identification, qualification and selection of contract manufacturing partners, and develops transfer plans and acceptance criteria.
- Apply GMP and GDP principles to assembly and test procedures and documentation.
- Supports qualification and validation activities for manufacturing processes or equipment.
Tasks and Responsibilities:
- Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols
- Interacts with engineering, R&D, marketing, operations or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identified
- Performs internal and external vendor audits to assure adherence to company SOPs and regulatory requirements, prepares written reports and follow-up to resolve findings
- Performs external site qualification activities, as well as continual quality oversight (e.g. audits) of external vendors.
- Preferred: B.A./B.S. in Mechanical Engineering, Manufacturing Engineering, or Industrial Engineering
- 7-10 years of relevant experience in the medical device industry with 5 years minimum as a Manager.
- Demonstrated ability to work effectively with all levels of a rapidly growing start up organization.
- An approachable individual who provides a high level of teamwork and cross-functional collaboration.
- Travel estimate: approximately up to 25%
- Background in Document Control
- Quality audit experience
- Regulatory Affairs Certification
- Capital equipment assembly and test experience
Applicants should send cover letter and resume to firstname.lastname@example.org
Miroculus believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.