Sr Supplier Quality Engineer

Location Type: Not Specified

Industry:

Company: Bioventus

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 Sr Supplier Quality Engineer manages and coordinates activities for critical quality systems elements (such a Supplier Quality, CAPA, Quality Audits, Process Improvements) to maintain compliance with and conformance to current U.S. FDA, ISO and other applicable regulatory and governmental requirements. The Sr. Supplier Quality Engineer advocates Quality Assurance best practices throughout the organization through example and training
What you’ll be doing:

• Supports Bioventus Global Supplier Quality process and is a significant contributor to other quality assurance services such as CAPA, Quality Audits, promoting supplier/Bioventus operations partnerships, and reporting on outcome related to product quality, as well assisting Quality Assurance in the maintenance of supplier quality in compliance with internal and external requirements and regulations.
• Conducts configuration control and review 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.
• Assists Supplier Quality during annual review of supplier risk and performance.
• May assist Supplier Quality and Supply Chain during sourcing activities.
• Closely works with Supplier Quality to issue, oversee, review and approve Supplier Corrective Actions.
• Ensure that internal procedures and forms used to implement the Quality Management System are effective and aligned with all internal and external requirements, specifically related (but not limited) to Supplier Quality.
• Adopts 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 as required by the needs of the organization.
• Assists Supplier Assurance during supplier qualification or requalification, including managing and executing manufacturing readiness reviews and conducting feasibility testing.
• Assists Supplier Quality Assurance during supplier audits; serves as the attendant technical expert during these reviews.
• Partners with Supplier Quality Assurance during supplier meetings, including meeting, creation of agenda, determining attendees and ensuring proper decorum is maintained during such interactions. Disseminates meeting minutes and critical updates to cross-functional partners and upper management.
• Oversees, reviews and approves NCRs, process verification and validation and other similar activities where suppliers require Bioventus approval.
• Oversees components of the risk management file (for manufacturing activities outsourced to the supplier) to ensure continuous alignment with ISO 14971:2019 including verification that controls identified within risk documents are fully implemented and verified to be effective. Oversees updates to risk management files at the supplier based on post market surveillance and other manufacturing data.
• Ensure the raw materials used in the manufacturing of Bioventus products are assessed for applicable RoHS/Reach compliance.
• Works with Manufacturing, engineering and other departments to address product non-conformities traceable to deficiencies in raw materials, components, finished devices, other goods and services provided by Bioventus’ contract manufacturers and service providers.
• Works with Supplier Quality, Design Quality Engineering, program management and other functions for qualification of suppliers as part of design and development activities.
• 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 process improvements, NCRs, CAPAs, investigations, etc.
• 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.

What you’ll bring to the table:

• Bachelor’s degree (Masters preferred), in an Engineering discipline or equivalent technical background, with emphasis or experience in systems and/or software.
• 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.

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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.