Contraline is a medical device company that is developing a novel long-lasting, non-hormonal, reversible male contraceptive.
Contraline is seeking a Director of Quality Assurance to lead and provide strategic functional support to the quality system. This role will have quality management system compliance, product quality monitoring and improvement, and process improvement. The Director will serve as a liaison between the company and various governmental agencies and regulatory bodies, including, but not limited to, the FDA. This role is an executive position that reports directly to the COO.
- Ongoing development and maintenance of the Quality Management System to ensure that it meets FDA cGMP/QSR, ISO 13485, and 21 CFR 820
- Reviewing and/or writing new SOPs, internal and supplier audits, as well as the company’s documentation and training programs.
- Regular reporting of quality metrics to management during reviews.
- Ensuring that Design Control activities such as DHF maintenance, risk management, requirements management and traceability, design verification, design validation, and post market surveillance activities are compliant.
- Leading oversight of contract manufacturing quality functions for device. This includes oversight of contract manufacturers, DHR documentation, quality metrics, and supplier management.
- Establish, lead, and execute Quality projects, provide day-to-day Quality direction to ensure that teams deliver on their commitments, and ensure that Quality milestones are achieved without delay.
- Ensure that Quality plans are aligned with the company’s goals and accountabilities.
Applicants must meet the following criteria:
- BS in engineering or related technical field is required.
- Minimum 5-10 years of experience in the medical device quality assurance role
- Proven leadership in formulating and implementing strategies to ensure product quality and quality management system compliance with regulations.
- Ability to effectively implement continual improvement to increase efficiency and promote simplification while maintaining or increasing compliance
- Expertise in FDA QSR, ISO13485, and 21 CFR 820 and working knowledge of FDA regulations.
- Demonstrated ability to lead, communicate, interact and influence effectively at technical and management levels across functions, entities and external agencies
- Excellent communication, organization, and project management skills
- Creative, flexible, and independent thinking
- Works well in small, cross-functional teams