Ultradent, a global name in oral health, is looking for a Stability Engineer. The Stability Engineer is responsible for coordinating stability activities for the organization. Stability is a product’s resistance to degradation throughout its shelf life and is a crucial aspect of product development and quality control. The Stability Engineer develops and implements product stability studies acting as an integrated resource to teams from R&D to Regulatory Affairs. This includes supporting stability activities for new product development and throughout the product lifecycle.
- Oversees the overall stability program under direction from the Stability Engineering Manager, while working with subject matter experts within R&D and other departments.
- Writes stability protocols and reports
- Maintains control and logging in of studies and samples.
- Interfaces with R&D, Formulation, Quality, Regulatory and other departments regarding stability.
WHAT YOU’LL NEED TO SUCCEED:
- Bachelor’s Degree in engineering or science related field or equivalent work experience.
- Minimum of 1 years’ experience directly related to the following areas: stability, excursion studies, storage and shipping conditions, real time testing, accelerated aging, and cold storage testing. Recent college graduates are encouraged to apply.
- Strong understanding of FDA regulations and ISO13485 requirements for stability is ideal.
- Strong knowledge of ANSI standards pertaining to calibrations.
WHAT WE’RE LOOKING FOR IN YOU:
- Excellent communication skills, both verbal and written.
- Ability to speak about stability on a technical level to auditors from FDA, notified body, etc.
- Basic understanding of calibration.
- Understanding of good laboratory practices in relation to GMP.
- Strong organizational skills
- Proficiency with MS Office and other work-related computer software.
Ultradent is an Equal Opportunity and Affirmative Action Employer. We are a global culture where differences are sought after, welcomed, and embraced. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
VEVRAA Federal Contractor: For more information please contact us at [email protected].
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What We Do
Ultradent Products, Inc., is a leading developer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s mission is to improve the level of dental health care and to make dental procedures more predictable and efficient. Consistent with its mission, Ultradent works to improve the quality of life and the health of individuals through financial and charitable programs.
Ultradent evolved from a dentist’s quest to create more effective dental products. Dr. Dan Fischer's desire to develop more advanced dental products led him to create products that would set future industry standards.
Today, Ultradent has subsidiaries in Germany, Italy, Brazil, Spain, Malaysia, China, and Japan, employing approximately 1,900 individuals and manufacturing and packaging more than 500 materials, devices, and instruments. While Ultradent has expanded into a worldwide company, the majority of its professional and skilled manufacturing positions have remained in the United States, providing jobs for a diverse community of Americans. Ultradent is committed to local production and is proud to be a USA manufacturer.
Ultradent’s products are used worldwide by dentists, group practices, dental and veterinary labs, government agencies, and universities. Ultradent has continued its development efforts, holding dozens of patents and trademarks on unique products, materials, devices, and application techniques
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