Director of Quality Assurance and Regulatory Affairs will be responsible for oversight Quality Assurance, Quality Control, Document Control, and Regulatory Affairs. This position has the ultimate jurisdiction where quality related issues arise within the divisions of Assembly and Packaging and/or Laboratory Production.
- Model personal Lean Philosophy 5S behaviors in creating a continuously improving, clean, well-organized and self-maintaining work environment.
- Work closely with team members and others to motivate and improve 5S knowledge and implementation.
- Follow a continuous improvement approach for team accountability for achieving high performance SQDC (Safety, Quality, Delivery, & Cost) targets through a visual work environment.
- Comply with company ethics, code of conduct, policies, and best practices, with a commitment to safety in the workplace, valuing of diversity, and promotion of a harassment-free environment.
- Responsible for oversight of the Quality System for SDC Operations as described in the Quality Manual.
- Ensure compliance with federal and international regulations relating to the organization’s products and quality system.
- Ensures that procedures and work instructions are followed.
- Performs quality assessment of critical suppliers.
- Oversees onsite inspections and communications with regulatory bodies.
- Completes and submits 510(k) documents to the Federal Drug Administration (FDA) for clearance on relevant products.
- Maintains compliance with ISO quality systems.
- Sets goals and expectations for direct reports.
- Ensures all QA/QC employees have the appropriate skills, knowledge, abilities, training and tools to execute their responsibilities.
- Manages/supervise employees with regards to employee relations, training, disciplinary issues, performance management, etc.
- Responsible for achieving organization and department goals.
- Controls expenses and labor costs to conform to the manufacturing budget.
- Complies with all safety and regulatory standards.
- Perform other duties as assigned by management
- Apply the company Quality Policy and actively monitor quality of outcomes in the performance of all assigned tasks.
- Bachelor’s Degree in scientific or relevant field.
- Five years’ experience in a manufacturing environment.
- Ten or more years’ experience in a manufacturing environment preferred.
- Experience in FDA regulated industry preferred.
- Experience with ISO9001, ISO13485, and ISO17025 requirements.
- Three or more years’ supervisory or management experience preferred.
- General knowledge of global Quality standards and regulatory compliance requirements.
- Any equivalent combination of education and experience.