Boston Scientific is looking to solve challenges in the health industry by hiring a Senior Quality Systems Manager to oversee and direct quality and regulatory compliance within a functional group, ensuring adherence to Corporate, FDA, and ISO requirements.
Requirements
- Minimum of 8 years of quality experience in a medical device or regulated environment or similar related work experience
- Minimum of 2 years of direct or indirect management experience
- Demonstrated ability to lead effectively across a broad set of cross-functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment
- Experience in project management / demonstratable project management skillset.
Responsibilities
- Manage external and internal Quality System audits by preparing the organization, developing a plan with resourcing, and executing the audit
- Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
- Approves documents defining the Quality System.
- Participates with manufacturing management at all levels in problems of quality and reliability.
- Reviews Quality Assurance Manuals for updating in line with product and policy changes.
Other
- Recruits, coaches and develops organizational talent.
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Creates an entrepreneurial environment.
- Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
- Demonstrates effective change leadership.
- Builds strategic partnerships to further departmental and organizational objectives.
- Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
- Develops, monitors and appropriately adjusts the annual budget for department(s).
- Bachelor's Degree
- Demonstrated ability to be an inclusive leader with proven experience collaborating with peers
- Demonstrated ability to influence and drive consensus across multiple parties in a highly matrixed organization
- Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
- Ability to be innovative and drive new perspectives based on industry standards and best practices
- High sense of urgency and commitment to execution
- Proven adaptability, comfortable with change and demonstrated ability to react and respond to a fast-changing environment
- Excellent interpersonal and communication skills
- This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
- Candidates will be subject to a prohibited substance test as a requirement.
