Senior Quality Engineer

at  Boston Scientific Corporation

REQUIRED QUALIFICATIONS:

• Minimum Bachelor’s Degree in Science or Engineering
• Six Sigma Black Belt or equivalent certification trainings and/or experience
• Advanced knowledge and working experience of lean-six sigma related tools, including, but not limited to SPC, FMEA, MSA, DOE and Quality Systems
• 5+ years’ experience in manufacturing or equivalent with direct experience in a GMP regulated environment, preferably in a quality/engineering role
• Experience in the medical device or pharmaceutical industry is an advantage
• Working knowledge of validation methodology, including computer systems validations
• Enhanced understanding of processes and how they impact the quality of a product, including but not limited to, process capability, critical to quality, critical processing parameters and monitoring
• Ability to travel domestically and/or internationally up to 20%

PREFERRED QUALIFICATIONS:

• Highly influential individual who has successfully influenced and sustained change in working environments with a wide array of existing challenges
• Ability to quickly establish business relationships with colleagues and external partners
• Experience with implementation of computer systems to support manufacturing and testing capabilitiesExperience influencing and implementing change in a unionized environment
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  Requisition ID: 594922
  As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
  So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
  Job Segment: Quality Engineer, Six Sigma Black Belt, Senior Quality Engineer, Lean Six Sigma, Six Sigma, Engineering, Managemen

ABOUT THE ROLE

At Boston Scientific, we improve the quality of our products and processes to drive improvement in patient outcomes. We are looking for a highly motivated, influential, and experienced Senior Quality Engineer* to work with 2+ of Boston Scientific’s most critical suppliers. In this role, you will effectively influence suppliers to make meaningful quality improvements and drive further harmonization towards our world class quality management system. The Sr. QE acts as a quality subject matter expert and partner to internal and external stakeholders to influence and drive quality related improvements to product and process, inside and outside of Boston Scientific. This role involves taking a flexible approach in the application of traditional quality tools and methodologies to innovate mutually beneficial solutions for Boston Scientific and our most strategic suppliers.

You may be suited for this role if you have had experience working directly with a variety of quality systems, principles, tools, and methodologies. You already have favorite quality tools and know when it is most beneficial to use one over another. You can see many different pathways to solve a problem and have a strong ability to influence others towards embedding quality into their process to eliminate recurrence of nonconformances. You have exceptional patience and perseverance, and consistently bring value to your colleagues and business partners. Your colleagues look up to you as someone who sets a great example for others and who is committed to helping everyone grow together.

• Please note, for Canadian applicants without professional engineering designation (P.Eng), the title of this role is amended to “Senior Quality Engineering Analyst” in order to abide by provincial law.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Drive internal quality improvements in process, product, and systems
• End to end quality responsibility for 2+ critical suppliers within the BSC network, including:
• Proactively build and sustain a collaborative quality relationship with critical suppliers – lead collaborative quality boards and track/trend/act on supplier performance indicators
• Successfully influence preventive actions and strong quality focus in-process and systems
• Issuing and driving supplier corrective actions to root cause and highly effective solutions
• Work in a cross-functional supplier management team to lead reduction of risks in supply chain and production process to drive improvement in quality and usability of product
• Collaborate with sourcing to execute and promote adherence to quality agreements
• Collaborate and participate with Global Supplier Quality teams (component, SFMD etc.) to contribute to the successful implementation of the site, divisional and global quality objectives
• Collaborate with Design Assurance, Post Market Surveillance and R&D to effectively launch new product variations
• Initiate, review and/or approve supplier process, equipment, and material changes, as necessary
• Liaise with suppliers as the voice for quality on related business deliverables
• Bring value to suppliers and internal BSC through access to training materials, collaborative improvements and supporting their internal (and mutually beneficial) improvement initiatives