CIS Senior Manager - NMD

Recruiter: Spencer Gregory Hale

Senior Quality Manager - CIS

About This Role:

The Senior CIS (Complaint Investigation Site) Manager provides strategic leadership to ensure complaint handling and investigation systems, processes, and staffing are appropriately designed, implemented, and continuously improved to maintain an effective, compliant post-market surveillance program. Leading a cross-functional team, this role drives timely, high-quality complaint intake, triage, and investigation execution, ensuring thorough documentation, defensible root cause analyses, and effective linkage to corrective and preventive actions (CAPA) and risk management. The Senior CIS Manager ensures compliance with applicable regulations and standards by establishing governance for investigation quality, cycle-time performance, data integrity, and trend monitoring, and by ensuring accurate and timely escalation and reporting to regulatory authorities as required (e.g., MDR/vigilance and other reportability determinations). This position partners closely with Quality, Regulatory, Manufacturing, Engineering, and Service to minimize recurrence of field issues through rigorous returned product analysis, robust containment and correction, and verification of effectiveness. The role also drives continuous improvement and cost-of-poor-quality reduction by using complaint data and analytics to prioritize systemic actions, streamline investigation workflows, and improve product and process reliability.

Your Responsibilities Will Include:

• Recruit, coach and develop organizational talent
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
• Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team
• Lead a team of employees responsible for in depth technical analysis and product trending and act as liaison between the CIS team and cross-functional partners (R&D, Manufacturing, Design Assurance, Supplier Quality)
• Provides general guidance to the Product Returns supervision
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly
• Develop department budget, execute and monitor spend
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership
• Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture
• Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills
• Monitor and ensure compliance with company policies and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained to assure compliance and adherence to the BSC Quality Policy
• Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects
• Own and drive deliverables related to quality systems, product quality, and compliance Own and drives commercial product monitoring and all related product sustainment activities
• Provide guidance, mentoring and resolution across site functions regarding quality system compliance
• Develop and implements quality strategies; seeks innovative approaches to attaining quality goals
• Ensure adherence to the Global Corporate Metrics for complaint investigations
• Directly interface with internal and external audit activities

What We're Looking For In You:

Required Qualifications:

• Minimum of a Bachelors degree in engineering or another related technical field
• Minimum of 7 years of related quality/complaint investigation experience
• Minimum of 3 years of direct management experience
• Medical device experience or regulated industry experience
• Experience leading both technical and non-technical teams
• Regulatory compliance experience in the areas of medical devices
• Experience with complaint investigation processes

Preferred Qualifications:

• Advanced degree in technical fields
• Knowledge of continuous improvement tools (Lean, Six Sigma, Robotic Process Automation)
• Familiarity with Post Market Acquisition integrations
• Strong analytical skills
• Demonstrated leadership ability
• Passion for continuous improvement

Requisition ID:628683

Minimum Salary:$125800

Maximum Salary: $239000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.