Boston Scientific Sr Supplier QA Manager 

United States, Minnesota 

878445899

Spencer Gregory Hale

Senior Supplier QA Manager

About this role:

This role represents a dynamic leadership opportunity within the Global Supplier Quality Engineering organization. You will partner with Operations across multiple BSC manufacturing sites and products to Deliver Excellence in direct materials. This individual will be responsible for leading a team of Supplier Quality Engineers that have quality ownership of Metals category suppliers and the direct materials they source. SQE are core members of multi-functional Global Sourcing Category Teams that define and execute sourcing strategies. They take an active ownership role within the Material Controls QS sub-process, owning assessments for supplier onboarding, surveillance of the Approved Vendor List, and supporting internal and external QMS audits. They work with BSC cross-functional partners and suppliers to resolve material related yield and quality issues and provide quality oversight of Incoming Quality Assurance (IQA). This individual will manage the Metals SQE team to execute daily activities efficiently and effectively, leaving time to engage in projects including root cause problem solving, proactive quality initiatives, and material cost reduction. All to ensure the manufacture of the highest quality and reliability medical devices on the market, while maintaining compliance to BSC QS requirements. You will be representing the North American region as a key member of a regionally aligned global leadership team.

Your Responsibilities Will Include:

• Keep the organization's vision and values at the forefront of decision making and action.
• Foster a global culture to further BSC's world class Global Sourcing vision
• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Lead your team through setting a clear strategy, developing objectives, and delivering to approved milestones
• Monitor and evaluate projects to milestones, and regularly communicate on progress and results.
• Identify and initiate cross-department, cross-business unit, and/or cross-site projects.
• Build and maintain strategic and trusting cross-functional relationships within the supported divisions, plants, and Category Teams.
• Provide direction, coaching, mentoring, and development for engineering personnel.
• Coach sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Influence Sr. Management on potential improvements or enhancement to the quality system and processes.
• Monitor compliance to Regulations, BSC QS requirements, and company policies and procedures
• Contribute to the development and monitoring of area budget.
• Provide appropriate issue oversight, risk evaluation, and action to mitigate impact to Boston Scientific

Minimum Requirements:

• Bachelor’s Degree in an Engineering or Science discipline
• 7+ years of related and progressive work experience, preferably within the medical device industry or other highly regulated industry
• 5+ years demonstrated success leading and developing high performing teams
• Have a passion for leading people to bring out their best
• A proven track record of collaboration
• Someone who understands how to get the day-to-day tasks completed efficiently to make time for individuals to develop professionally and personally
• Someone that thinks practically and understands decision making in a risk-based, time sensitive environment
• A strong influencer and communicator (written and verbal) who can effectively influence and communicate up, down, and across a global organization.
• Proven mind set of proactive continuous improvement
• Ability to thrive in a fast-paced operations environment

Preferred Qualifications:

• Mechanical Engineering background
• Experience with metals manufacturing (stamping, precision machining, wire, etc)
• Prior experience within a quality function
• A working knowledge of Medical Device regulations (21CFR820 ISO13485), specifically Material Controls Quality System requirements
• A working knowledge of the CAPA process
• ASQ certification or Lead Assessor certification

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.