Boston Scientific Senior Quality Engineer 

Canada, Ontario, Ottawa 

911814707

About the role

*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

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 capabilities
• Experience influencing and implementing change in a unionized environment