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Quality Assurance Manager

The Quality Manager is responsible for maintaining ISO 13485 quality system and QSR implementation compliance through proper documentation and recording, analyzing quality system performance data, and coordinating with multi-discipline groups companywide and overseas manufacturing sites. This position is responsible for the QA department team, including hiring, training, retaining, and leading the group.

Essential Duties and Responsibilities:

  • Quality Manager appointed by top management to serve as the Management Rep, as defined by the FDA Quality System requirements 21 CFR Part 820.20 (b) (3). This responsibility includes: interfacing with the FDA and other external agencies as required, ensuring the establishment and effective maintenance of the quality system, and reporting on the performance of the system to top management per CTK procedures.
  • Ensure that the entire quality management system at CTK and its manufacturing sites are updated and well maintained and held in compliance with ISO, FDA’s QSR, regulatory, and system requirements;
  • Independently conduct periodic audits and improve procedures of quality systems, quality assurance, and quality control departments. Track any related & necessary projects from initiation to completion.
  • All improvements and new activities that impact the quality system are handled in compliance with quality system requirement
  • Identify any weaknesses in the quality system
  • Improve department quality practice
  • Facilitate continuous improvement
  • Lead CTK’s quality strategy and support and execute the global quality strategy
  • Facilitate regular reviews of the effectiveness of the Quality System, providing regular updates to top management, including information on all new developments and/or requirements that the Company needs to act upon or consider in its future plans and make recommendations as is appropriate
  • Organize awareness campaigns and activities on quality, regulatory compliance, and customer requirements throughout the organization
  • Serve as an expert in the execution of quality systems and operational excellent initiatives that enhance performance, improve quality, reduce cost, and generate sustainable quality improvements
  • Develop and maintain a comprehensive, personal understanding of the company’s global strategy, technologies, operations, and financial performance
  • Lead an effective quality organizational structure:
  • Train and mentor staff for individual growth, building high-performing team members
  • Encourage the QA team to be examples of full compliance to the organization, leading by example in all areas including the achievement of company adjectives
  • Responsible for goal setting and the training of a productive team with high standards and attention to detail
  • Promote a culture of inclusion, recognition, and accountability and improve product quality by managing product, company, system, compliance, and Supplier audits including the monitoring of supplier corrective action
  • Work as liaison with Suppliers of outsourced processes including BGB in China
  • Support device regulatory findings and act as liaison to other agencies including the FDA, WHO, TGA, ISO notified body, customer auditors, etc. ensuring all quality certifications are up to date and handling all questions on quality
  • Plan and manage the Quality department budget and allocate necessary resources to meet objectives and timelines
  • Maintain a calendar of QA events that focuses on CTK’s quality policy that ensures monitoring of procedures and processes leading to compliance with ISO, FDA’s QSR, regulatory, and system requirements
  • Other duties may be assigned
  • 8 years related experience and/ or training; or equivalent combination of education and experience in diagnosis IVD QA.
  • Proficient in Microsoft Office, including Excel Spreadsheets, PowerPoint, Word, and Filemaker
  • Must possess excellent interpersonal skills and communication
  • Excellent in writing reports and procedures.

Please email your resume to Leona  Evaristo at levaristo@ctkbiotech.com

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