Staff Quality Systems Engineer
San Carlos
Regulatory & Quality – Quality /
Full-time /
On-site
Who Are We?
We are a technology company operating at the intersection of AI, Physics and Biology to automate the physical exam from data collection to triage and routing to make preventive personalized healthcare available to everyone.
Position:
The Staff Quality Systems Engineer is responsible for supporting
product and software development activities and the Quality Management System (QMS) to ensure design controls and QMS related activities are in compliance with industry standards and regulatory requirements.
Responsibilities
- Quality Management System (QMS): Supporting the QMS to ensure compliance with ISO 13485, FDA regulations, and other applicable regulations and standards.
- Design Control: Represent Quality to ensure design control deliverables/ activities are completed and documented per the company procedures. Design Control activities including reviewing and approving design description documents, requirement documents, risk management activities and documentation, V&V protocol and report, trace matrices, design reviews, and DHF.
- Document Control: Manage the creation, review, approval, distribution, and archiving of quality documents, including SOPs, work instructions, and quality manuals.
- Continuous Improvement: Identify opportunities for process improvements within the QMS and document control processes. Collaborate with other departments to implement system improvements to enhance efficiency and compliance.
- Training: Develop and implement training programs related to quality processes and regulatory requirements. Ensure all employees are trained and maintain training records.
- Compliance: Ensure all quality documents and processes comply with regulatory requirements and industry standards.
- Audits: Prepare for and participate in internal and external audits. Ensure all documentation is audit-ready and address any findings promptly.
- Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality requirements are met throughout the product lifecycle.
- Reporting: Generate and analyze quality metrics and reports. Present findings to management and recommend corrective actions as needed.
Experience
- Minimum of 8 years in Quality Assurance/Quality Engineering role from Medical Device or other regulated industry
- Bachelor’s degree in a related field (e.g. Quality Management, Engineering)
- In-depth knowledge of relevant Regulations and standards (e.g. FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971)
- Experience with administration of QMS and document control systems.
- Lead auditor experience preferred
- Working knowledge of design controls, risk management, software development life cycle, and statistical techniques.
- Strong written and verbal communication skills and ability to collaborate effectively
- Proficient in the use of Microsoft Office Suite
$160,000 - $210,000 a year
Q Bio is an Equal Opportunity Employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
