What are the responsibilities and job description for the Medical Device Quality Assurance position at Illuminant Surgical?
đź’ˇ Company
Illuminant Surgical is a medical technology company based in Culver City, CA. Founded by two Stanford engineers, Illuminant combines the sensors and bioengineering expertise of the two founders to address the unmet needs for more accurate and safer spinal surgery. Illuminant has raised from prominent venture firms including YCombinator and has secured federal funding from the National Institutes of Health and National Science Foundation. Illuminant comprises a team of clinical, engineering, regulatory, and business professionals with decades of experience in developing medical device technologies.
đź’Ľ The Role
We are looking for an individual to collaborate with a team of software and hardware engineers to author and release critical design documentation to enable regulatory submission of Illuminant’s hardware and software product.
Longer term, this individual will support ongoing quality assurance and manufacturing. This individual will be responsible for managing the Quality System. This position shall ensure compliance with FDA design control requirements and other applicable requirements and standards during the product development life cycle to support regulatory approval submission, and transfer to manufacturing, and commercial release.
Our ideal candidate is intrinsically motivated to create a culture of quality that ensures the safe and effective delivery of medical technology to patients everywhere. They will have deep experience in interpreting and putting into practice guidelines set by federal and international regulatory bodies. They will have a deep understanding of 21 CFR Part 820, and ISO 13485.
They must have excellent written and oral communication abilities to lead training and motivate cross-disciplinary groups to abide by quality principles. They are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early employee.
To excel in this role, you will have worked in quality roles at medical device companies in its design and manufacturing phases.
đź“ť Responsibilities
🏆 Qualifications
Illuminant Surgical is a medical technology company based in Culver City, CA. Founded by two Stanford engineers, Illuminant combines the sensors and bioengineering expertise of the two founders to address the unmet needs for more accurate and safer spinal surgery. Illuminant has raised from prominent venture firms including YCombinator and has secured federal funding from the National Institutes of Health and National Science Foundation. Illuminant comprises a team of clinical, engineering, regulatory, and business professionals with decades of experience in developing medical device technologies.
đź’Ľ The Role
We are looking for an individual to collaborate with a team of software and hardware engineers to author and release critical design documentation to enable regulatory submission of Illuminant’s hardware and software product.
Longer term, this individual will support ongoing quality assurance and manufacturing. This individual will be responsible for managing the Quality System. This position shall ensure compliance with FDA design control requirements and other applicable requirements and standards during the product development life cycle to support regulatory approval submission, and transfer to manufacturing, and commercial release.
Our ideal candidate is intrinsically motivated to create a culture of quality that ensures the safe and effective delivery of medical technology to patients everywhere. They will have deep experience in interpreting and putting into practice guidelines set by federal and international regulatory bodies. They will have a deep understanding of 21 CFR Part 820, and ISO 13485.
They must have excellent written and oral communication abilities to lead training and motivate cross-disciplinary groups to abide by quality principles. They are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early employee.
To excel in this role, you will have worked in quality roles at medical device companies in its design and manufacturing phases.
đź“ť Responsibilities
- Oversee all aspects of quality assurance, document control, and quality control to ensure compliance with FDA QSR requirements, and plan for transition to QMSR
- Support the development of safe and effective products, including Software in Medical Devices (SiMD), by applying design assurance principles, facilitating/verifying compliance to design control requirements, and implementing risk management throughout the development life cycle.
- Review, prepare, and/or execute test protocols and reports and validations.
- Create and/or revise quality system procedures to ensure compliance or drive improvement.
- Conduct new employee quality system training and required training on new/revised quality system procedures and quality policy, and provide guidance/training on applicable standards.
- Keep abreast of applicable regulations and standards, perform and/or coordinate gap assessment of new quality system regulations/standards
- Establish, validate, and manage the electronic document control system, including the control of external documents.
- Interface with contract manufacturers and suppliers to analyze data and provide solutions for quality issues.
- Manage and/or conduct internal and external audits.
- Regularly exercises independent judgment and discretion regarding matters of significance.
- Prepares quality compliance status reports, trend findings, and escalates critical issues that warrant further actions.
- May supervise one or more individuals.
- Perform special projects and other duties as assigned.
🏆 Qualifications
- Must reside in Los Angeles Metropolitan Area. This is an in-person role.
- Bachelor’s degree in life sciences and/or engineering
- At least five years of medical device quality experience
- Thorough knowledge of FDA QSR, ISO 13485, ISO 14971, and ISO 62366-1
- Experience supporting 510(k) and/or De Novo regulatory submissions
- Prior work experience with Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD)
- Training in, or working knowledge of, IEC 62304
- Training in, or working knowledge of, Six Sigma or Lean principles
- ASQ or RAC Certification
Salary : $80,000 - $120,000