Job SummaryThe Director, Quality Operations is responsible for management and continuous improvement of Plant Quality Systems including customer and internal corrective/preventive actions and effectiveness, customer specification management, internal audit, and testing and inspection processes. This role provides training, leadership, and professional growth and development for all team members.
Essential Functions- Ensure that facilities, equipment, materials, organization, processes, procedures, and products align with ISO 9001, ISO 13485, and applicable standards.
- Lead the quality assurance processes across different regions and product lines, ensuring products meet quality standards.
- Provide oversight to disposition of high-risk product nonconformances; assure adequate technical investigations and appropriate corrective actions are in place to prevent reoccurrence.
- Develop, implement, and maintain quality management systems and policies.
- Support internal audits and certification audits at SaniSure and its suppliers.
- Provide leadership to the Quality team to proactively identify quality signals and trends and drive actions needed to mitigate adverse quality trends.
- Train and mentor quality personnel on quality control processes and best practices.
- Ensure appropriate staff development and training in areas of responsibility.
- Ensure documentation of quality processes follows industry standards.
- Stay updated on industry regulations and changes in quality standards.
- Set and track department goals and objectives in alignment with company goals.
- Identify areas for cost reduction and increased efficiency.
- Address employee concerns and resolve conflicts; coordinate with Human Resources as needed.
- Collaborate cross-functionally and across the SaniSure organization to ensure Quality Management System processes are implemented, maintained, and performed in accordance with established procedures and applicable standards.
- Champion, maintain, and support continuous improvement to the product QMS; monitor and identify areas for improvement and ensure remediation.
- Support development and management of Quality Agreements, external audits of suppliers, and third parties with Supply Chain.
- Ensure team members adhere to company policies and procedures including PPE and ISO regulations.
- Perform other duties as assigned.
Education- Bachelor's degree in Quality Management, Engineering, or a related field; Master's degree preferred.
Required Experience & Competencies- 5+ years of experience in quality management or a similar role.
- Strong knowledge of quality assurance methodologies (e.g., Six Sigma, ISO 9001, ISO 13485).
- Must have 3+ years of recent experience in pharmaceutical, biopharma, or medical device industries.
- Excellent analytical and problem-solving skills.
- Solid background in quality assurance, regulatory compliance, and process improvement.
- Strong communication and leadership abilities.
- Proficient in quality management software and tools.
- Certification in Quality Management (e.g., CQE, CQM).
- Skilled professional able to lead and motivate a team, manage performance, and resolve conflicts.
- Excellent verbal and written communication skills.
- Able to manage multiple priorities and meet deadlines.
- Competent in interpreting data, generating reports, and making data-driven decisions.
- Proactive approach to identifying opportunities for improvement and driving positive change.
