Quality Systems Manager

Additional Location(s): N/A

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.

At Boston Scientific, the Quality Systems Manager I will be responsible for managing a staff of quality system professionals with primary responsibilities for the Internal Audit and CAPA processes at the Arden Hills site. This role will report to the Senior Quality Systems Manager and partner with cross-functional teams and a global network to execute, standardize, and improve these processes. Additional activities will include providing guidance and mentoring across site functions regarding quality system compliance.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be on site in Arden Hills, MN 3 days a week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Site ownership of systems including Internal Audit and CAPA.
• Establish, support, and promote a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System requirements and appropriate regulations.
• Ensure employees are trained to do their work and their training is documented.
• Lead a team of employees in the achievement of organizational goals; provide guidance and training to staff, assist them in attaining career goals, and recruit and maintain a high-performing team.
• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Manages Quality System activities/initiatives and communicates performance to senior leadership. Lead quality meetings regarding quality and/or compliance improvement.
• Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
• Drive quality projects of moderate scope.
• Review and approve NCEP, CAPA and Internal Audit documentation.
• Assist in development of department budget and monitor spending.
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly.
• Maintain and enhance cross-functional team relationships.
• Monitor and ensure compliance with company policies and procedures.
• Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support department, functional, site, divisional and/or corporate quality goals and priorities.

• Bachelors degree required with 5+ years of related work experience within medical device quality or related discipline or master’s degree with 0-2 years of experience
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and Internal Audit processes
• Demonstrated leadership ability
• Conflict management and negotiation skills
• Solid project management skills
• Excellent interpersonal skills
• Excellent written and verbal communication

• Subject Matter Expert level experience in BSC Quality Management System Processes and Sub-Processes and BSC systems.
• Compliance background in regulations and standards.

Minimum Salary: $ 102100

Maximum Salary: $ 194000

The anticipated compensation listed above and the value of core and optional employee benefits…