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Chief Quality Officer
1 week ago
We are seeking a Chief Quality Officer to lead our quality assurance team at BioLab Holdings, Inc. As the Chief Quality Officer, you will oversee the development and implementation of our quality management system, ensuring compliance with regulatory requirements, and leading our quality assurance team. This is a unique opportunity to join a dynamic and growing company committed to quality, safety, and innovation.
About Our Company
BioLab Sciences is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork. Since its founding, we have experienced explosive growth and are actively developing new technologies to innovate, improve the customer experience, and expand our market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company's mission.
Responsibilities
The ideal candidate will have deep experience in design and development efforts for medical devices governed under design controls, specifically as outlined in 21 CFR 820.30, and will have actively participated in the development of these systems. Key responsibilities include:
- Developing and executing a comprehensive quality strategy aligned with BioLab Sciences' corporate objectives and regulatory requirements.
- Establishing and driving a culture of quality excellence and continuous improvement across the organization.
- Leading the organizational transformation to support medical devices regulated under ISO 13485, ensuring seamless integration with existing regulatory frameworks.
- Developing long-term plans for QA/QC staffing and infrastructure to align with growth forecasts and strategic priorities.
- Developing and administering budgets, plans, and performance requirements linked to the quality assurance and quality control departments.
- Creating a comprehensive Quality Plan with clear deliverables, including performance metrics.