About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.
As a Manager/Sr. Manager of QMS at Lucira Health, you will be responsible for all aspects of QMS activities ranging from managing internal/external audits, QMS inputs to Document Control. This is a hands-on role requiring the application of diversified knowledge of Quality Management System (QMS). This position reports to the Director of Quality.
Core Job Responsibilities:
- Providing leadership to the organization in steering QMS activities including Audit Management, Management Review, Change Control, Document Control, and Training integration.
- Taking a lead role in the Quality Management Planning activities to ensure continued compliance, visibility, and appropriate planning for changes impacting the QMS.
- Maintaining enforcing, and managing a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Quality and Regulatory processes at all levels.
- Manages a staff of up to 5 individuals.
- Represent Quality for presenting and reviewing quality metrics.
- Provide guidance to ensure timely completion of metrics and data.
- Ensures that the organization follows the framework of ISO 13485:2016, CFR Part 820, IVDR.
- Supports the QMS organization by ensuring procedures and work instructions meet internal requirements and practices.
- Support manufacturing process instructions development & qualification.
- Support internal & external audits.
- Mentor, develop, and lead other team members.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Additional duties may be identified by functional management based on the current project/business objectives.
Education: B.S. Degree in Engineering of technical field; M.S. preferred.
Experience: 5+ Years of Quality/Regulatory experience in a medical device regulated industry and demonstrated use of Quality tools/methodologies.
Ability to identify areas of improvement.
Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485), FDA Software guidance of Verification & Validation.
Auditing experience in an FDA regulated Class 2 or 3 medical device environment to QSR CFR Part 820 and ISO 13485 Quality Systems.
Excellent communication, organizational and project management skills.
Prefer ASQ, Lead Auditor Certifications.
Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.