서울 중구에서 최고의 application specialist 채용공고 18개(지금 채용 중!)

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:

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.

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.

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