Job Description

Additional Locations: Canada-ON-Mississauga

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we\'ll give you the opportunity to harness all that\'s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we\'ll help you in advancing your skills and career. Here, you\'ll be supported in progressing - whatever your ambitions.

About the role

The primary activities for the Quality Engineer II role are to resolve issues with manufacturing processes and supplier materials for their assigned product line, and to work on continuous improvement activities. This role is expected to collaborate with stakeholders within the company on technical matters, and drive quality deliverables. This position ensures the continued effectiveness and compliance of products manufactured from their assigned areas.

Your responsibilities will include:

• Proactively investigates, identifies, and implements best-in-class quality practices.
• Conduct investigations related to quality issues in production and at incoming inspection.
• Coordinate Material Review Board activities to gain alignment and agreement on disposition, corrections and corrective actions related to non-conformances
• Lead Continuous improvement projects
• Review and approve process design documents, such as process validation and process control
• Review and approve manufacturing documents such as instructions, protocols, test methods, and process changes
• Partners with multiple functions (Process Engineering, Supply Chain, Manufacturing, Other Quality teams etc.) to ensure the high functioning of manufacturing lines to meet the demands of the customer and produce high-quality product
• Conducts layered process audits and spot audits.
• May give technical guidance to Quality Inspectors, or other quality staff assigned to work on common projects
• Adhere to all requirements of the Quality Management System.
• Demonstrate company values, work with integrity and be a supportive team member.
• Comply with the Health & Safety policies of the company and inform Management of unsafe working conditions.
• Other duties as required.

Required qualifications:

• Bachelor\'s Degree in Engineering required
• 4+ years related working experience in a manufacturing environment. Preferably from a regulated industry such as medical device, aerospace, pharma industries, etc.
• Demonstrated experience in resolving complex problems
• Demonstrated successful interdisciplinary collaboration in a team setting
• Demonstrated experience in conducting and facilitating audits
• Demonstrated experience in 5S, Lean Manufacturing, Six Sigma and Continuous Improvement methods
• Working knowledge of and experience of Good Manufacturing Practices, Quality Management Systems (ISO Standards)
• Strong expertise in analytical methods, statistical process analysis, measurement system analysis and GD&T
• Ability to write clearly and informatively technical documentation, correspondence, procedures and work flows
• Skilled interpersonally; strong negotiation and conflict management skills
• Demonstrated ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation

Preferred qualifications:

• Master\'s Degree in Engineering
• Understanding and working knowledge of Medical Device Quality Systems (ISO 13485) and Regulatory Requirement.
• Lean/Six Sigma Certification

Requisition ID: 568148

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!

Boston Scientific