Sr. Quality Systems Manager - Supplier Controls

Recruiter: Spencer Gregory Hale

Sr. Quality Systems Manager – Supplier Controls

About This Role:

Quality System Manger for the Global Quality System processes and systems relating to Material and Purchasing Controls. Develops strategies, priorities and objectives to ensure continued compliance of the BSC Quality System, supporting global quality goals, priorities, and compliance of the BSC Global Quality.  Leads a global team of Engineers and Project Leads to drive continuous improvement. Operates with a global perspective across BSC sites, business units, and functions.

Your Responsibilities Will Include:

• Keeps the organization's vision and values at the forefront of decision making and action.
• Leads team through setting a clear strategy and fosters a global culture to further BSC's world class sourcing vision
• Coaches sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Leads teams and projects to successful conclusions while achieving strategic milestones.
• Identifies and initiates cross-department, cross-business unit, and/or cross-site projects. 
• Maintains and enhances cross-functional team relationships within the divisions, plants, global functions, and Quality System Stewards, across the entire BSC network.     
• Monitors, evaluates, and provides summary reports on project progress and results.
• Provide project direction, coaching, and mentoring for engineering and technical team personnel.
• Builds strategic and trusting relationships through collaborations and teamwork.
• Develops future leaders through partnerships and mentoring.
• Influences Sr. Management on potential improvements or enhancement to quality systems and processes for the company.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, ISO, MDR regulations etc).
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Responsible for appropriate oversight, risk evaluation, and action to mitigate impact to Boston Scientific

What We’re Looking For In You:

Minimum Qualifications

• Bachelor's degree in Science, Health, or Engineering  
• 10+ years of relevant work experience in the medical device regulated industry
• Experience in supplier qualification, material qualification, and change control for direct materials.
• Experience with CAPAs (Corrective and Preventive Actions) and audit support
• Project management experience
• Strong presentation skills
• Strong communication skills
• Solid computer skills required including Excel, Word, Project and PowerPoint
• Potential global and US travel up to 50%

Preferred Qualifications

• MBA, or Master of Science
• Working knowledge of US and International regulations and standards applicable to BSC including 21CFR820, ISO 13485:2016, MDR and regional requirements
• Technical experience within the areas of Material Controls and Quality Management Systems
• Experience working with cross functions such as Quality Systems, Operations, Manufacturing Engineering, Sourcing, Regulatory, Research and Development, and Design Assurance.
• ASQ Certified CMQ/OE, CQE, CQA are a plus

Requisition ID: 620427 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

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 specific prohibited substance test 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.