
Quality Management Professional
5 days ago
About BioIntelliSense
BioIntelliSense is a cutting-edge company that specializes in developing innovative medical devices for continuous health monitoring and clinical intelligence. Our mission is to empower clinicians with actionable insights and improve patient outcomes. We are committed to delivering high-quality medical devices that meet the highest regulatory standards.
We are seeking a skilled Quality Engineer, Design Assurance to join our team and contribute to the development of our design control processes. This role will involve working closely with cross-functional teams to support new product introduction (NPI) and existing product sustaining processes.
The successful candidate will have hands-on experience with medical device software (SaDM) and IEC 62305, as well as strong written and verbal communication skills. They will be responsible for ensuring that our design control processes meet the highest regulatory standards, including FDA 21 CFR part 820, ISO 13485:2016, and European EU MDR.
Key Responsibilities:
- Develop and implement design control processes that ensure the quality and safety of our medical devices.
- Work closely with cross-functional teams to support NPI and existing product sustaining processes.
- Ensure that design control processes meet the highest regulatory standards, including FDA 21 CFR part 820, ISO 13485:2016, and European EU MDR.
- Provide continuous guidance to other teams and functions to promote compliant and best practice design control processes.
- Take ownership of the quality and consistency of products' Design History Files (DHF).
- Provide Quality content review of design control related deliverables.
- Provide Risk Management oversight per ISO 14971.
- Responsible for review and approval of project traceability matrices.
- Assist Regulatory FDA 510(k) submissions and other regulatory submissions.
What You'll Bring:
- Bachelor's or higher degree in engineering, technology, or science.
- 5+ years of experience in design control or design assurance functions in a medical device company.
- Hands-on experience with medical device software (SaDM) and IEC 62305.
- Hands-on experience with risk management activities per ISO 14971.
- Strong written and verbal communication skills.
- Strong interpersonal skills; Ability to interact with all levels and disciplines of employees.
- Organized and able to prioritize duties and responsibilities.
Our Benefits
BioIntelliSense offers a comprehensive benefits package, including medical/dental/vision/life/disability insurance, 401(k) auto contribution program, 11 paid holidays per year, generous paid time off, and a weekly lunch perk.
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