Are you ready to work for a more active world?
At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
Manages the end-to-end systems and activities for critical quality systems elements (such a Supplier Quality) to maintain compliance with and conformance to current U.S. FDA, ISO and other applicable regulatory and governmental requirements. Communicates QS best practices throughout the organization through example and training.What you'll be doingBachelor's Degree or equivalent experience is required.
3-4 years' combination of experience in quality systems and medical devices or related industry - prior experience with regulatory audits is preferred, but not required.
Knowledge of Quality Systems, FDA, ISO regulations and compliance is required.
Knowledge of other regulations (EU-MDR, Japanese, Australian, etc.) is a plus.
Strong communication and program management skills, both verbal and written with project management/coordination and technical writing experience is highly desirable.
Strong computer skills required especially in Microsoft Office.
ASQ certification is helpful, but not required.
Bioventus requires proof that new hires be fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from being vaccinated where allowable under the law. Documentation is required to be uploaded within the first week of employment.
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Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms ofdiversity andtake pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.