Quality Systems Specialist II (Finance)
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 doing
- Assists in maintaining and coordinating the Bioventus Global CAPA system.
- Assists and conducts internal audits as required by Quality Systems management.
- Adopt a metrics/KPI driven approach to measuring and improving quality by setting, monitoring and achieving project quality metrics - develops QMS strategies and inputs to realize overall goal of continuous improvement.
- Facilitates Bioventus' Supplier Quality process. Conducts supplier quality audits and reports on outcomes. Maintains supplier quality files in compliance with internal and external requirements and regulations. Conducts configuration control of external change requests from contract manufacturers. Communicates with suppliers and maintains supplier file, including service and installation records where applicable.
- Assists with data collection from sources of post-market surveillance, specifically for data obtained as part of supplier monitoring, or provides supplier quality data to Post Market Surveillance and Periodic Safety Update Reports.
- Ensures that internal procedures and forms used to implement the Quality Management System are effective and in alignment with all internal and external requirements, specifically related (but not limited) to CAPA, Supplier Quality and Internal Audit.
- Collaborates with Manufacturing, Operation, and Quality Assurance on CA/PAs and investigations.
- Collects, analyzes and prepares data for Quality and Management Review meetings.
- Review/authors Quality System procedures, protocols and reports, supports the development and performance of Quality Systems-related training and participates in internal/external compliance audits.
- Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
- Other duties as assigned by Management
- Bachelor'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.
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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 of diversity and take 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.
