About this role
Requistion ID : 83711 Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality, and effective solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
SUMMARY OF POSITION
For Korea: Own and Maintain Quality Management System for Medical Device import Management of 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) Manage post-market surveillance activities For Emerging Asia (India, Korea, Southeast Asia and Taiwan) Partner with regional and local stakeholders to deploy corporate quality initiatives, harmonize quality systems and processes. Support quality operations for assigned Emerging Asia markets. Monitor quality performance and risk trends and support continuous improvement activities within Korea and assigned Emerging Asia markets.
- This position does not have direct people management responsibilities. ( 본 포지션은 직접적인 인원 관리 책임을 포함하지 않습니다 .) DUTIES & RESPONSIBILITIES
- 1. Quality Management System (QMS) Own and maintain QMS for Korea operation Act as the registered Quality Management Representative for medical device import 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
- 5. Manage post-market surveillance activities Managed Post Market Surveillance (PMS) activities in accordance with MFDS requirements Act as coordinator for FSN, FCA and recall for imported devices
- 6. Support quality initiatives deployment for Emerging Asia Liaise with regional counterparts on QMS harmonization Gather and analyse quality risk trending Act as a point of contact between Korea and regional teams to track quality related project timelines and deliverables Coordinate with external vendors and regional teams to adapt quality policies and operational guidelines for local market compliance KNOWLEDGE, SKILLS & EXPERIENCE: University/ Bachelor’s Degree and Major in science or engineering preferred 6 years’ experience in Quality Assurance of medical device, pharmaceutical or food industries.
Candidates with more experience will be considered as Associate Quality Manager 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.
Equal Opportunity Employer
Dentsply Sirona is an Equal Opportunity Employer. All qualified applicants will be considered without unlawful discrimination or regard for race, color, religion, sex, sexual orientation, sexual or gender identity, national or ethnic origin, age, marital status, disability, genetic factors, military and veteran status, or any other characteristics protected by applicable local law. Eligibility: All successful applicants must be eligible to work in the country the position is based. Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected] . Agencies: Please note that Dentsply Sirona does not accept or respond to unsolicited requests or applications submitted by Recruitment Agencies/ Search Firms.
Notice on Fraudulent Job Offers: Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: careers.dentsplysirona.com .