Quality Assurance Specialist

SUMMARY OF POSITION:

• Own and Maintain Quality Management System
• Management of internal/external KGMP audit/inspections as company representative
• Ensure compliance with MFDS & Corporate QA requirements
• Quality oversight of the storage, release testing of products and distribution of medical device
• Manage quality related changes
• Manage Nonconformance and Corrective and Preventive Action (CAPA)

DUTIES & RESPONSIBILITIES

1. Quality Management System (QMS)

• Own and maintain QMS for Korea operation
• Ensure that all related systems/procedures and QMS documents are in full compliance with the corporate policies and local regulatory requirements
• Recommend and advise on quality aspects of systems, tools, equipment, suppliers and procedures to ensure an effective, efficient and reliable QMS for Korea operation
• Monitor and analyze the QMS processes for efficiency and improvement opportunities and implement actions to address the identified gaps
• Provide the needed documentation and training for QMS

2. Management of audit and inspections

• Lead KGMP inspections as company representative
• Coordinate with relevant teams to support efficient response(s) is provided during KGMP inspection
• Coordinate CAPA response to deviations or findings resulted from KGMP inspection
• Lead internal audit for Korea operation
• Host external quality related audits

3. Maintain quality operation

• Own and implement quality plan for Korea operation, monitor and report monthly metrics to Quality Senior leaders
• Manage quality related changes
• Manage Nonconformance and CAPA
• Act as the quality representative in global project participation for Korea deployment
• Support ad-hoc projects as quality representative to meet local regulations and corporate requirements

4. Quality oversight on product distribution

• Act as the quality representative to ensure products are adequately imported, stored and distributed in accordance with regulatory requirements
• Ensures external quality suppliers comply with regulatory standards and Dentsply Sirona quality requirements
• Establish and maintain robust, risk-based selection and governance framework for quality-related third-party suppliers
• Conduct routine on-site and remote audits of external partners. Approve supplier CAPA plan and action closure
• Act as the ultimate quality authority for compliance decisions, making evidence-based judgments free from operational or commercial influence

KNOWLEDGE, SKILLS & EXPERIENCE:

• University/Bachelor’s Degree and Major in science or engineering preferred
• More than 5 years’ experience in Quality Assurance of medical device, pharmaceutical or food industries
• Experience with KGMP inspection is a must
• Language proficiency: fluent in English and Korean
• Good experience with writing, changing and implementing QMS

COMPETENCIES:

Professional Qualities

• Understands technical and professional aspects of work and continually maintains technical knowledge.
• Customer-focused mindset: a professional attitude that places the customer's needs, satisfaction, and success at the center of every decision
• Compliance focus: adheres to quality related government laws, industry regulations, and internal policies
• Problem solving & Analysis: Analyzes issues and breaks them down into their component parts. Make systematic and rational judgments based on relevant information.
• Oral Communication: Speaks clearly, fluently, and in a compelling manner to both individuals and groups.
• Written Communication: Writes in a clear and concise manner, using appropriate grammar, style, and language for the reader.

Personal Qualities

• Interpersonal Sensitivity: Respect and work well with others in a sensitive and effective way.
• Flexibility: Successfully adapts to changing demands and conditions.
• Resilience: Maintains effective work behavior in the face of setbacks or pressure. Remains calm, stable and in control of themselves.
• Personal Motivation: Commits self to work hard toward goals. Shows enthusiasm and career commitment.