Staff Quality Engineer
Saratoga, CA /
Medical Devices – Regulatory /
At Mojo, we’re inventing new solutions that shift our focus away from our screens and devices, back to the world around us through Invisible Computing. Our team includes talented professionals with expertise in product design, user experience, applied physics, hardware, software, optics, photonics, electronics, chemistry, biology and vision science. Together, we’re creating a platform and solutions for enhancing human vision and achievement.
We are a well-funded startup building a ground-breaking consumer product. We are located in Saratoga, CA.
The Staff Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to cross-functional teams. Capable of self- direction and project management to ensure successful outcomes.
The Staff Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For New Product Development activities, this person will support projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with Mojo policies, while meeting all design control and other regulatory requirements.
For Sustaining Product activities, this person will support operational processes to realize predictable product flow while satisfying established Mojo Medical standards of quality. Successful performance requires close work with quality management, operations, engineering, suppliers and/or Mojo associates to assure compliance with all Mojo quality policies, procedures, and practices.
- Support product development and existing product sustaining activities to ensure work follows proper design control. Provide support to meet MOJO and regulatory requirements by participating as needed with product development teams to identify Quality needs, product improvements and customer requirements.
- Ensures adequate design control documentation and records are maintained to support life cycle of design history.
- Provide support of design control to ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and design history files and other activities as needed.
- Help create test fixtures and processes for modular testing of device.
- Responsible to creating or evaluate design verification plans and protocols.
- Execution of test protocols.
- The creation or evaluation of Verification and Validation data and writing the V&V reports. .
- Supporting design efforts to transferring into manufacturing to avoid increased risk.
- Support product and/or device shipping studies by providing quality and the FDA and ISO requirements, reviewing or generating protocols, assessing generated data and reviewing final reports.
- Participate in Risk Management activities appropriate to the initiative or situation.
- Monitor quality data from Product Incident Report process, Manufacturing reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering and Regulatory.
- Review and assess work performed by R&D and other MOJO business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
- Quality Record Management: tracking and holding quality update meetings for CAPA, NCMR, Deviations, etc.
- QC Engineering reviews, e.g., Specifications, Work Instructions, BOMs, etc.
- Conduct, as needed, supplier evaluations and supplier audits.
- Work with suppliers to establish required controls to meet MOJO and regulatory requirements.
- Support FDA or Notified body inspections as needed.
- Support activities relating to Field Corrective Actions, when needed.
- Managing training plans and ensuring training requirements are met by monitoring and reporting Training Metrics.
Qualifications and Assets
- A minimum of a master’s degree, PhD preferred, required in a scientific discipline: Mechanical or Electrical Engineering related science.
- Lead testing strategy to meet ISO 60601, ISO 10993, FCC and other standards for electronic medical device.
- Certified Quality Engineering (CQE) desirable.
- A minimum of 10 years of experience in a quality function.
- A minimum of 5 years of experience working in an FDA, ISO 13485:2016 and MDR regulated environment.
- Experience with QMS/PLM electronic document control software.
- Robust understanding of QSR, Design Control, ISO 13485:2016, ISO 14971 and GMPs as defined in CFR 820 and other industry standards.
- Excellent people interaction, team building and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.
If solving challenging problems and shaping the future interests you, come join us at our offices in Saratoga, CA just outside of San Jose. Along with competitive compensation employee perks include flexible time off, access to full health benefits and a stocked fridge and pantry in the office. Even if you don’t see your dream job on our openings page, you can still apply for it with the “Create your own position” option.