200+ applicants
Dentsply Sirona · 3 days ago
Quality Engineer - Packaging
United States
Full-time
Remote
Mid Level
3+ years exp
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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 a regulatory plan for possible registration updates.
+ Registration updates primarily focused on EMEA, CIS, and APAC.
+ Guidance on the 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
Qualification
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Required
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.
Preferred
This position may require travelling up to 25% to support the project. Travel can vary depending on the project stage and status.
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10,001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (5)
2022 (14)
2021 (6)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
unknown1987-08-21IPO· nasdaq:XRAY
Leadership Team
Vicky Hain
Senior Customer Service Manager |Dental Orthodontics Endodontics Implants
Recent News
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2024-05-25
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