Job Description
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.
The Project Specialist, Quality Assurance supports the successful implementation of quality facing projects or initiatives. This role coordinates and leads projects involving data analysis, inspection technical needs, and quality process improvements for company-wide impact across the quality team. The Project Specialist will also drive a quality culture, instill a vision for planning and communication, and promote quality objectives and policy.
What you'll be doing - Partners with leaders to manage projects related to core Quality Assurance processes and projects that manage and analyze large amounts of data (complaint handling and post market surveillance) to identify Quality trends for Management review,
- Directly responsible for leading projects from the planning and administration of the project, and providing technical leadership and assistance through the development process,
- Supports other functions across the Quality Assurance organization, specifically with respect to complaint handling and processing, CAPA ownership, Quality Audits and activities related to project improvement and quality plans.
- Assists and collaborates cross-functionally to ensure deliverables for Post-Market surveillance are tracked and fulfilled per established product schedules,
- Develop and maintain the scope, timeline, and budget for individual projects and coordinate these efforts,
- Lead quality activities and technical operations improvements including inspection, tool, and fixture design support, equipment automation, documentation, process validation, risk mitigation and quality issues,
- Clearly communicate project status, priorities, issues, choices, solutions, and changes in the project plan to management,
- Deploys solutions to improve project management effectiveness across the quality organization,
- Interact with internal leaders at all levels of the organization and external with vendors and scientific leaders,
- Using Lean and Six Sigma principles, identify and implement processes to reduce waste and improve manufacturing throughput.
- Holds oneself and other 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.
What you'll bring to the table - Bachelor's degree in a technical discipline or equivalent technical experience, with emphasis in Quality Control/Engineering preferred.
- Minimum 5 years medical device quality operations experience is preferred.
- Minimum 2 years' experience with customer facing projects within the medical device industry, and understanding and ability to interpret regulations and guidelines governing medical devices, including applied knowledgeable of FDA, ISO and applicable international regulations required.
- Demonstrates ability to form and motivate cross-functional teams to accomplish project related objectives.
- Ability to adapt & learn quickly, good written & verbal communication and responsiveness, ability to work well within a team and relate to all levels within the company.
- Understanding and experience in applying quality assurance and control tools (including GD&T, statistical analysis, DOE, gauge R&R, SPC, process validation and verification).
- Understanding and experience in applying quality engineering concepts such as process capability analysis, risk assessment, PFMEA and DFMEA.
Are you the top talent we are looking for? Apply now! Hit the "Apply" button to send us your resume and cover letter.
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. Bioventus
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