Quality Assurance Manager

Position Summary:

Implement and manage the quality management and quality improvement programs. Administer quality assurance and compliance functions and ensures programs and services are implemented to meet or surpass ISO 13485 standard.

Duties and responsibilities:

• Oversee and maintain Quality Management System (QMS).
• Maintain a document management system with audit trails.
• Create and maintain Device History Record (DHF) and corelating processes pertaining ISO 13485.
• Train employees on the appropriate areas of the QMS and ensure appropriate documents are available to all employees.
• Ensure we are always prepared for inspections and audits.
• Provide a simple system to manage the quality process while modifying products or launching new products.
• Good written and oral communication skills to write easy-to-follow Standard Operating Procedures (SOP) and train others to follow the procedures.
• Meet or exceed customer expectations on the quality of our products and services.
• Provide direction and leadership to drive the quality process.
• Monitor and engage with employees to ensure quality.
• Work with the Production Manager to implement and monitor SOPs for production operations that meet required standards.
• Implement and enforce quality control and tracking programs to meet quality objectives.
• Prepare and maintain quality reports.
• Work with customer service and product managers to respond to complaints and institute CAPA reports.
• Perform quality checks and due diligence on vendors ability to provide quality products.
• Coordinate and collaborate with 3rd party vendors and consultants on various applicable studies, services, and regulatory requirements.
• Review the performance of staff and organize necessary interventions for improvement.
• Ensure efficient collaboration and coordination between relevant departments.
• Improve processes and policies in support of organizational goals.
• Formulate and implement departmental and organizational policies and procedures to maximize output.
• Monitor adherence to rules, regulations, and procedures.
• Other duties as assigned.

Required Qualifications:

• Bachelor's degree in life sciences preferably in Molecular, Biology, Chemistry, or similar field.
• Knowledge and experience in production and manufacturing processes and techniques.
• Knowledge of quality management systems.
• Knowledge of FDA submission process.
• Knowledge of health and safety standards and compliance.
• A minimum of 5 years' experience in an ISO accredited facility.
• Proficient with computer applications including Microsoft Office.

Preferred Qualifications:

• Knowledge of ISO Standard 13485.
• Knowledge of ISO Standard 18385.
• Knowledge of IQOQPQ requirements.
• Regulatory awareness of international standards pertaining to medical device distribution and sales.
• MS in Regulatory Affairs Certification (RAC), or equivalent American Society of Quality (ASQ) certification.
• Knowledge of workflow for manufacturing, packaging, and kitting using desiccants, plastics, and adhesives.
• Knowledge of Greenlight Guru or similar document control systems.
• Knowledge of business, finance, and management principles.