Quality Systems Analyst IV

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.

• Oversees Bioventus Global Supplier Quality process and is significant contributor to other quality systems such as CAPA, Quality Audits Conducts supplier quality and internal 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.
• 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.
• Reviews and approves CAPA phases and Supplier Corrective Actions.
• Plans and executes quality audits, from agenda preparation to report writing.
• 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 Supplier Quality.
• 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.
• Collects, analyzes, prepares and presents 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.
• Collaborates with Manufacturing, Operation, and Quality Assurance on CA/PAs and investigations.
• 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.

• College Degree and/or equivalent Quality Systems Experience and eight years' experience in medical devices or related industry - prior experience with regulatory audits is preferred, but not required.
• Ability to manage critical quality systems elements with limited input from management.
• Demonstrated experience in implementing and maintaining quality systems.
• Knowledge of Quality Systems, FDA, ISO regulations and compliance is expected for this role. 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.
• ISO 13485:2016 Auditor and Lead Auditor certification is highly desired.
• Strong computer skills required, especially in Microsoft Office and electronic Quality Management Systems.
• 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.