Requistion ID : 77585

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.

Quality Engineer - Packaging

THIS POSITION CAN BE LOCATED FROM ANY DS LOCATION WITHIN EU OR USA

Under general supervision, participate in the various Quality Engineering efforts focused on sustainable packaging which include but are not limited to development, verification, validation, key supplier quality deliverables, test method and regulatory strategy, planning and guidance. The QE III will play a crucial role in providing Quality and Regulatory guidance to support sustainable packaging solutions for Dentsply Sirona’s dental equipment and consumable products. The individual will collaborate closely with cross-functional teams and external suppliers to support new packaging technologies and strategies, with a focus on product from QARA perspective.

Key Responsibilities:

• The individual will be primarily responsible for providing Quality and Regulatory guidance, strategy, planning around new packaging solutions verification and validation. The individual will collaborate closely with cross-functional teams and external suppliers to support new packaging technologies and strategies from QARA perspective.

• This individual will be responsible for guidance, strategy and verification for packaging validations for new sustainable packaging. The responsibilities include but not limited to:

• Establishment of testing and specification requirements for new sustainable packaging including sterile packaging.

• Provide guidance on relevant industry standard and ensure alignment with the project team.

• Verification of product stability during shipping, storage and transportation with new packaging.

• Oversight and approvals on packaging validation protocols and reports for dental equipment and consumables product within Dentsply Sirona.

• Provide guidance on supplier documentation, qualification of suppliers and establishing quality agreements.

• This individual will be responsible for guidance, strategy and regulatory planning for possible registration updates resulting from new sustainable packaging. The responsibilities include but not limited to:

• Closely collaborate with Regulatory experts and create regulatory plan for possible registration updates.

• Registration updates primarily focused in EMEA, CIS and APAC.

• Guidance on use of electronic Instructions for use or Directions for use.

• Oversight and approvals of packaging compliance and labeling requirements for sustainable packaging

• Ensure compliance and documentation for change management process related to sustainable packaging changes.

• Develop protocols for package design, packaging process validation, and package shelf-life testing for external laboratory testing and in alignment with necessary and compliance change control impact assessment criteria.

• Provide guidance on barcoding as applicable

Education & Experience:

• Bachelor’s degree in Engineering, Material Sciences, or related field.

• 3 to 5 years of experience in quality engineering in a regulated industry preferably with experience on packaging validations for medical devices

• Knowledge of testing requirements for packaging changes.

• Familiar with registration requirements around packaging changes primarily in EMEA, CIS and APAC regions.

• Good understanding of cGMP, ISO 9000 / 9001 / 13485 and FDA Quality Systems.

This position may require travelling up to 25% to support the project. Travel can vary depending on the project stage and status

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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 careers@dentsplysirona.com (careers@dentsply.com) . Please be sure to include “Accommodation Request” in the subject.