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Quality Assurance Lead in Women's Health Medical Device Startup
2 months ago
Oasicare is a pioneering medical device startup dedicated to enhancing the standard of care for women. Our mission is to develop innovative solutions that improve maternal health outcomes.
The PositionWe are seeking an experienced Quality Assurance professional to lead the development and implementation of our Quality Management System (QMS). This role involves creating and maintaining quality procedures, driving audits, and promoting a culture of continuous improvement.
Key Responsibilities- Develop and implement QMS policies and procedures
- Conduct audits and assessments to ensure compliance with regulatory requirements
- Manage quality documentation, including SOPs, quality manuals, and records
- Lead continuous improvement initiatives and manage corrective and preventive actions (CAPA)
- Collaborate with cross-functional teams to ensure quality is integrated into all aspects of the business
- Bachelor's or Master's degree in a relevant field, such as Quality Management, Biomedical Engineering, or Life Sciences
- Minimum 5-7 years of experience in quality management within the medical device industry
- Expertise in regulatory requirements, including ISO 13485 and CE marking
- Strong leadership, project management, and communication skills
Oasicare is a dynamic and supportive team of professionals dedicated to improving women's health. We offer a collaborative and fast-paced work environment with opportunities for growth and development.
