QA Specialist - Hasselt, Belgium

☞ Dentsply Sirona

看过: 160

更新日: 16-11-2025

位置: Hasselt Limburg

类别: 质量保证/质量控制

行业: Medical Devices

水平: Entry level

工作类型: Full-time

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工作内容

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history 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 dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

Working At Dentsply Sirona You Are Able To

Develop faster - with our commitment to the best professional development.

Perform better - as part of a high-performance, empowering culture.

Shape an industry - with a market leader that continues to drive innovation.

Make a difference -by helping improve oral health worldwide.

MISSION

As QUALITY ASSURANCE SPECIALIST you will contribute to the international Quality Assurance department. This department is process owner of our Quality Management System (QMS).

Main Responsibilities
  • Assisting in QMS processes and documentation maintenance in compliance with ISO 13485, ISO 62304, IEC 62366, ISO 14971, 21CFR 820 and other relevant standards and regulations relevant for medical device manufacturers, participate in process improvements
  • Document control coordination and administration
  • Coordinating site-related Change Orders for processes and products
  • Control and maintenance of Technical Documentation of medical device products, including software
  • Supplier Quality Control regard outsourced services and products
  • Assisting in software validation, usability and risk management activities
  • Assisting is quality issues investigation, initiating and follow-up of CAPA, NCR
  • Assisting in post-market surveillance actions
  • Identifying relevant quality-related training needs and deliver internal trainings
  • Support Regulatory Affairs in product registrations, including software as medical device
  • Participate in global QA/RA projects
  • Participating in Internal and External audits, support of local process owners during preparation to the audits and the audits follow-up
  • Cooperate with other product groups / pillars / departments / sites on quality related aspects relevant for sites and product in scope of DI NV certification
  • Deputy for QA Manager for software products
PROFILE
  • You have min. 2 years of experience in a similar function or min 3 years in medical device or other regulated sphere
  • You have knowledge of regulatory standards e.g. ISO13485, ISO62304, IEC62366, ISO14971, 21CFR820
  • You have a basic knowledge of design controls
  • You are familiar with root cause analysis and other quality tools
  • You are willing to travel from time to time and you are fluent in English
  • Preferably you are a certified internal auditor and experienced in supplier audits too
  • You like to think proactively, you work efficiently and in close collaboration with your colleagues within the projects
  • You know how to set your priorities and how to respect deadlines
Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.

If you need assistance with completing the online application due to a disability, please send an accommodation request to
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最后期限: 31-12-2025

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