Director or Vice President, Quality Assurance is responsible for maintaining ISO 13485 quality system and QSR implementation compliance through continuous improvement, regular analysis of quality performance, constant quality system training, and monitoring by coordinating with multi-discipline groups companywide and overseas manufacturing sites. This position is also responsible for the QA department’s team, including hiring, training, retaining, and leading the group.
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 of effective quality system maintenance, and reporting on the system’s performance to top management per CTK procedures.
Ensure that the entire quality management system at CTK and its manufacturing sites are updated, well maintained, and held in compliance with ISO, FDA’s QSR, regulatory and system requirements:
- Periodically review and revise procedures of quality systems, quality assurance, and quality control departments.
- Identify weaknesses in the quality system, initiate and carry out the improvements
- Lead quality planning process on new activities that impact the quality
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
- Serve as an expert in the execution of quality systems and operational excellence initiatives that enhance performance, improve quality, reduce cost, and generate sustainable quality improvements
- Maintain and improve product quality by managing product, company, system, compliance and supplier audits, including the monitoring of supplier corrective actions
- Work as a liaison with an oversea manufacturing facility in China
- Support device regulatory filings 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
Lead an effective quality organizational structure:
- Organize awareness campaigns and activities on quality, regulatory compliance, and customer requirements throughout the organization
- Train and mentor staff for individual growth, building high-performing team members
- Responsible for goal setting and the training of a productive QA team with high standards and attention to detail, encourage the team to be examples of full compliance to the organization, leading by example in all areas, including the achievement of company objectives
- Plan and manage the department budget and allocates 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
- Promote a culture of inclusion, recognition, and accountability
Other duties may be assigned
- Minimum 8 years of related experience in a QA position within an IVD manufacturing company
- Master or Ph.D. in a related biological science
- Must possess excellent interpersonal skills, effective and concise communication that drives change and improvement company-wide.
- excellent skills in writing reports and procedures
- Proficient in analyzing, summarizing, and creating cohesive action plans from data
- Computer skills: proficient in Microsoft Office
- Statistical analysis skills