Quality Assurance Manager

le contenu du travail

Responsibilities

• Establish and maintain the company’s quality system, ensuring compliance and addressing quality incidents in laboratory and production areas.
• Promote and implement the QA management system, organizing training programs to enhance employee understanding and adherence.
• Lead the application and preparation forPrecision medicine molecular testing laboratories (精準醫療分子檢測實驗室認證) for successful certification.
• Develop, review, and maintain comprehensive quality documents to support standardized operations.
• Support and actively participate in internal and external audits, driving continuous improvement efforts.
• Collaborate with cross-functional teams to formulate product inspection plans and ensure compliance with quality standards.
• Monitor key quality indicators, analyze data, and initiate corrective and preventive actions.
• Provide guidance and support to teams, fostering a culture of continuous improvement.
• Stay updated on industry trends and regulations, enhancing the company’s quality systems.
• Collaborate with suppliers, customers, and regulatory agencies to address quality concerns.
• Mentor and develop quality team members through training and coaching.
• Conduct regular management reviews of the quality system, proposing enhancement strategies.

Qualifications

• Bachelor’s degree or higher in a science or engineering discipline.
• Minimum of 3 years of experience in the medical device, diagnostics, clinical laboratory, biopharmaceutical, or biotechnology industry.
• Experience in establishing or implementing LDTS (Laboratory Developed Tests and Services) and ISO 13485, or familiarity with CAP (College of American Pathologists), GLP (Good Laboratory Practice), and GMP (Good Manufacturing Practice) requirements.
• Medical Technologist certification is preferred.
• Previous experience as a senior-level technician involved in quality management and audit activities is a plus.
• Experience in in-vitro diagnostics (IVD) and medical device product development and manufacturing is a plus.
• Demonstrated knowledge of molecular biology is a plus.