Global Complaint Management Operations Director

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

About the role:
The Director of Global Complaint Management Operations will lead multiple teams across Neuromodulation, Peripheral Interventions, Endoscopy, Urology Divisions and Coyol Supporting Services. This Director will be responsible for developing, defining and executing a clear strategy for industry-leading post market complaint management.  The strategy and associated execution are key to enabling PMQA to deliver increasing value to our patients, customers and company by supporting advancement of established divisional, global and BSC-level strategies and goals that meet external regulatory requirements.

 

The Director will have strategic and operational accountability and oversight over post market quality teams, activities and related infrastructure supporting the overall complaint handling process in accordance with relevant global regulations.  The focus will be on understanding, documenting, and communicating device performance through timely capture of field performance inputs, comprehensive investigation and analysis of relevant supporting data, and consistent assessment of reporting obligations in accordance with evolving world wide regulatory agencies. A key aspect of this role includes strong partnership with divisional and global stakeholders to communicate product performance aligned with clinical and risk management product profiles.

 

This role will report to VP, Global Quality Systems and Post Market Quality Assurance and work in partnership with divisional Quality and cross-functional partners, regulatory and compliance leadership, PMQA functional leaders and other stakeholders, with accountability to achieve/support localized, divisional goals, while enabling, maintaining and evolving appropriate company-wide harmonization. 

 
Your responsibilities include:

• Strategic and operational planning/execution: Develop a cascading/supporting strategy and strategic initiatives reflective of an industry-leading Post Market QA function enabling BSC, Global Quality, Post Market QA and the Division to achieve specific goals in alignment with patient-centric quality. Demonstrate successful execution and continuous improvement via achievement of KPIs/specific measures and demonstration of value provided. Goals are expansive and inclusive of compliance, financial, operational and business considerations, and include support and preparedness for new products and acquisitions.
• People Management: Effectively lead the team in planning and managing tasks and achieving deliverables according to established plans and goals; effectively manage performance and encourage/support development of team members. Ensure overall functional excellence within team and foster a culture of effective influence and collaboration for results.
• Complaint intake:  Ensure process and tools to capture feedback are optimized to collect comprehensive information; provide education on complaint reporting requirements to worldwide BSC employees.  Requires strong collaboration with commercial organization to maximize value and adoption/compliance.
• Complaint management: Oversee global complaint management process, practices and outcomes, with a key goal of documenting, assessing and communicating performance feedback on market approved BSC product portfolio in accordance with external regulations.  Priority is to ensure patient safety and draw conclusions that enable product improvements.  End-to-end communication, both internally within BSC and to external customers and regulators, must be clear, accurate and consistent. ​
• Regulatory Reporting: Ensure consistent compliance to worldwide vigilance reporting regulations across all divisions and products.  Partner with quality writing board and risk management teams to ensure written communications are complete and align with overall product risk profile.
• Collaborate with stakeholders: Partner with QA/RA and relevant BSC teams and leadership on projects/programs and infrastructure work as needed and appropriate in to assure mutual success. Collaboration with divisional partners enables Post Market QA to be an optimally effective partner in achieving goals and delivering products of the highest quality. Work closely with and collaborate with Post Market QA peers/leaders to ensure BSC-wide consistency, compliance an