Sr. Quality Systems Manager - Supplier Controls

Boston Scientific•Saint Paul, MN

11d•$82,600 - $156,900

About The Position

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.

Requirements

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%

Nice To Haves

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

Responsibilities

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