Executive, Quality Assurance (Operation) - Growth-Minded Organization

Job Responsibilities 

• Responsible for the planning and execution of QA strategies and procedures to assure compliance with all applicable regulatory requirements, quality system regulation and current good manufacturing practices (cGMP) requirements.
• Develop, direct, monitor, evaluate, and communicate QA program to meet company objectives and comply with all applicable national and international standards.  
• Assessing customer requirements and ensuring that these are met.
• Provide training to QA supervisors and inspectors and evaluate the effectiveness.
• Supervising and guiding supervisors and inspectors.
• Communicate with external quality assurance officers during on-site inspections.
• Other assigned duties as required.

Qualification and Experience

• A bachelor’s degree or equivalent from an accredited college or university, preferably in Scientific or Engineering discipline is required.
• Minimum three years’ experience in quality assurance, with at least two years’ experience at the management level in a regulated environment is preferred.
• Must have previous experience in auditing, and developing total quality systems.

Other Personal Capabilities

• Sound ability to think creatively and adapt thinking and actions to new directions.
• Sound leaderships skills and the ability to measure personnel and project required.
• Strong attention to details and follow-through skills.
• Ability to interface effectively with senior management, auditors and regulators.
• Ability to handle multi-tasks and work under limited supervision.
• Ability to perform statistical analysis for medical devices.