Director of Quality Systems and Compliance
1 day ago
The Director of Quality Systems and Compliance will be responsible for the design, development, deployment, and maintenance of the company's Quality System. This individual will serve as the primary interface with external regulatory agencies for audits and ensure the Quality System is continually compliant with all applicable regulations and standards.
Key Responsibilities- Develop and maintain a proactive and preventive quality systems culture throughout the business.
- Manage and develop a team of quality systems and compliance managers to drive organizational goals and objectives.
- Ensure compliance with global quality system requirements for medical devices, including FDA, ISO 13485, EU MDR, and MDSAP.
- Manage quality system audits with regulatory agencies and notified bodies.
- Develop and maintain a learning culture throughout the organization, including effective training material and processes.
- Oversee the quality change management process and ensure all product and process changes are appropriately evaluated.
- Direct the company's post-market surveillance program and manage product recalls.
- Extensive experience with FDA, ISO 13485, EU MDR, and global quality system requirements for medical devices.
- Strong analytical skills, including trend and statistical analysis.
- Ability to use process development tools, such as Lean Six Sigma.
- Leadership skills, including the ability to communicate and interact with all levels of the organization.
- Strong proofreading and writing skills, as well as exemplary attention to detail.
- Demonstrated organizational and prioritization skills.
- Requires a four-year degree in a technical/science/engineering field.
- Minimum 10 years' overall experience with at least 5 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on quality systems.
- A minimum of 5 years in a supervisory/management role.
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