
Executive Quality Assurance Director
2 days ago
The role of the Quality Assurance Manager is to oversee and implement quality control measures across various product lines, ensuring compliance with regulatory standards.
Key Responsibilities:
- Develop and execute a comprehensive quality plan to guarantee adherence to quality system requirements.
- Manage documentation related to Quality System guidelines, maintaining accuracy and currency.
- Lead cross-functional projects and determine QA timelines, plans, and strategies, driving collaboration among teams.
- Oversee Design Control Program, including design input and output documentation, risk analyses, verification, and validation activities, as well as formal design reviews.
- Provide strategic leadership for developing and directing Quality Assurance and Quality improvement initiatives, fostering a culture of excellence.
- Manage internal quality audit program, assessing improvement initiatives resulting from all Quality Audits, and implementing corrective actions.
- Collaborate with Production and Development teams to ensure seamless product supply and introduction of new products.
- Train company personnel in corporate Quality System, promoting knowledge sharing and best practices.
- Establish an auditing program and lead compliance audits of third-party suppliers, manufacturers, and distributors, maintaining strong relationships with external partners.
- Report on performance of quality system, non-compliance issues, and recommended actions, providing valuable insights for continuous improvement.
Requirements:
- Minimum 3-5 years of Quality Systems supervisory/management experience within a related industry, demonstrating expertise and leadership skills.
- Experience interacting with regulatory authorities, quality management systems, and quality system audits, showcasing adaptability and professionalism.
- Working knowledge of design control processes, with the ability to analyze complex problems and develop effective solutions.
- Strong interpersonal skills, with the ability to effectively communicate with all levels within the organization and external parties.
- Proven problem-solving ability with attention to root cause, fostering a culture of accountability and continuous learning.
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