Associate Director, Quality

As the Associate Director of Quality at DELFI Diagnostics, you'll oversee the development and maintenance of our Quality Management System (QMS), ensuring compliance with essential regulations like FDA 21 CFR Part 820 and ISO 13485. Your role will include leading audits, managing corrective actions, and supporting cross-functional teams during inspections and new product implementations. You'll have a chance to drive quality improvements, making a real impact on our life-saving diagnostic solutions.

To succeed as an Associate Director of Quality at DELFI Diagnostics, you'll need a Bachelor’s degree in a relevant field, along with at least 10 years of experience in quality systems, and 7 years specializing in IVD medical device design and development. Proficiency in FDA regulations, strong leadership skills, and the ability to foster relationships across teams are essential to excel in this role.

While not strictly mandatory, having a background in molecular diagnostics is preferred for the Associate Director, Quality position at DELFI Diagnostics. Understanding CAP/CLIA standards and regulations will vastly enhance your ability to lead quality initiatives and ensure compliance, thereby contributing significantly to our mission of transforming cancer detection.

The work culture at DELFI Diagnostics is rooted in collaboration and diversity. As an Associate Director of Quality, you will be part of a passionate team that values collective intelligence and mutual respect. We emphasize the importance of empathy and integrity while pursuing our mission to improve health outcomes worldwide through life-changing science.

At DELFI Diagnostics, the Associate Director, Quality role offers an extensive opportunity for professional growth. You will lead critical quality initiatives impacting our innovative IVD products, collaborate with various departments, and contribute to pivotal changes in healthcare. Through continuous learning and engagement in quality management, you’ll have room to further develop your career while making a difference in people’s lives.

In past positions, I ensured compliance by staying updated on regulatory standards, conducting regular audits, and implementing robust quality management systems tailored to the specific requirements. This involved collaborating closely with cross-functional teams to maintain transparency and ensure all processes met or exceeded required guidelines.

My experience with CAPA processes includes identifying non-conformances through routine review and analysis, leading investigations to determine root causes, and developing preventive measures. I emphasize thorough documentation and follow-up to ensure that the corrective actions implemented result in sustainable improvements.

I foster a culture of quality by prioritizing open communication and continuous training. I encourage team members to voice their concerns and suggestions regarding quality improvements and ensure that they have access to resources and training that enhance their understanding and commitment to our quality goals.

Handling audits involves thorough preparation well in advance. I ensure all documentation is organized and easily accessible, and I lead teams through mock audits to identify any potential gaps in our processes. During the actual audit, I maintain transparent communication with the auditors and view them as partners in improving our quality management.

Risk management is fundamental to quality processes as it allows us to proactively identify and mitigate potential issues before they escalate. In my previous roles, I have implemented rigorous risk assessment protocols to evaluate processes and products, ensuring actions are taken to minimize risks to patient safety and product effectiveness.

I stay informed about changes in quality regulations and standards by subscribing to industry publications, attending relevant conferences, and participating in professional associations. Networking with peers and being proactive about continuous education also helps me align our quality systems with the latest requirements.

In a previous role, I led a quality improvement project that streamlined our document control process. By introducing a digital management system, we reduced document retrieval times by 50% and significantly decreased the number of errors in documentation, resulting in enhanced compliance and efficiency across our operations.

In fast-paced environments, I prioritize quality objectives by aligning them with organizational goals, ensuring they are achievable and measurable. I implement a framework for regularly assessing progress against these objectives, allowing for adjustments as necessary while maintaining our commitment to excellence.

Mentoring junior team members involves providing hands-on training, pairing them with experienced colleagues, and encouraging them to take ownership of small projects. I foster an environment of support and constructive feedback to help them grow into effective quality professionals who embody our team's values.

The role of an Associate Director, Quality in a diagnostic company is to lead and manage the quality management systems, ensure regulatory compliance, and foster a culture of quality throughout the organization. This requires strategic thinking, strong leadership skills, and the ability to work collaboratively across departments to enhance overall quality outcomes.