Manager, Quality Assurance

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 Manager - Quality Assurance, leads and directs key aspects of the Quality Assurance and Quality Systems functions for the business under the leadership of the Site Director of Quality Assurance. This role manages key quality assurance elements (see Key Responsibilities, below), specifically, Complaint handling and Post-Market Surveillance, Quality Audits (Internal and External), Management Review and CAPA/Investigations. The Manager - Quality Assurance and is also responsible for assisting the Site Director of Quality Assurance with all compliance responsibilities for FDA, Notified Body, Health Canada, JPAL, and other regulatory authorities.

What you'll be doing

• Has direct oversite of Complaint handling, Post-Market Surveillance (PMS), Quality Audits (Internal and External), Management Review and CAPA., in addition to ensuring overall compliance to applicable internal and external regulatory requirements. Prepares the organization for regulatory audits (e.g., MDSAP) and ensures successful completion through a system of internal audits. 
• Maintains an effective and compliant Complaint handling process – ensures that metrics established for effectiveness of the complaint handling process are monitored, and that goals established by the organization are met. Prepares for and hosts complaint board meetings and ensures the adverse trends and issues are addressed and escalated appropriately.
• Oversees the Post Market Surveillance system – chairs PMS board meetings and works with Clinical and Medical Affairs to ensure that PMS deliverables (i.e. PMS plans, reports, PSURs) are planned for and completed on time. Provides PMS data for periodic risk management (file) review and update. Conducts Risk Management Review in collaboration with cross-functional teams to ensure that PMS data is included.
• Maintains the Quality Audit system at Bioventus. Ensures that internal audits are planned and works with the Management Representative to prepare for External Audits. Represents the organization during external audits – manages front and back rooms during audits by defining roles and responsibilities, including identification of subject matter experts. Creates and maintains processes, procedures and playbooks for planned and unannounced external audits. 
• Plans and prepares for Management Review. Oversees completion of the Management Review slide-deck and compiles the Management Review report in alignment with internal and external requirements.
• Oversee and maintains the CAPA system. Ensures that all CAPA metrics are established and that internal and external audit findings and other non-conformances, in general, are assessed for escalation to CAPA. Mentors and assists CAPA owners. Maintains the investigation process as a precursor to CAPA.
• Other general duties include mentoring and developing direct reports and imbuing a quality culture at Bioventus. Collaborates with Supplier Quality, Document Control, Training and Quality Operations departments to maintain the Bioventus QMS is a state of substantial compliance. Oversees quality improvement efforts including creation and oversite of Quality Improvement Plans.
• Oversees/assists with Operations Quality activities across multiple sites. 
• 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.
• Attract, develop and retain talent.  Ensure focus and alignment with functional and company goals.  Provide employees with continuous feedback and coaching using talent-and-performance management tools 
• Other duties as assigned by the Director of Quality Assurance Operations.
   

What you'll bring to the table

• Bachelor’s degree, or equivalent experience within medical device/pharma quality field, is required.
• 5-8 years of experience within the Medical Device industry
• Extensive experience and exposure to external Notified Body and Competent authority quality audits; demonstrated ability to manage and conduct these audits with little to no oversite from site management. 
• Extensive knowledge of FDA 21 CFR 820, Part 11, ISO 13485, EU-MDR, and MDSAP requirements.
• Experience and ability to lead a team of direct reports, with strong management, c