Boston Scientific Sr Manager Product Complaint 

Costa Rica, Alajuela Province, El Amparo 

900508722

Hybrid Roles:

About the role:

Plan, develop and maintain Post Market Surveillance compliance programs, policies, and processes. Create and champion improvement in the application of Quality System. Interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. May serve as liaison between the company and various governmental agencies. Work directly with operating entities to ensure that Post Market Surveillance product complaint management processes are performed as required. May manage work done offsite and through 3rd party vendors. Work closely with CISs and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

You're Responsibilities include:

• Recruit, coach and develop organizational talent.
• Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and facilitate training and training support for the Post Market Surveillance organization.
• Work cross-functionally to identify and resolve issues.
• Determine appropriate staff levels, schedules and resources.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

What We’re Looking For:

• Bachelor's degree in Engineering
• English Level desired: B2+
• Experience: 10+ years
• Or an equivalent combination of education and experience.