Quality Engineer II

Remote Eligible: Hybrid

Onsite Location(s): Mississauga, ON, CA

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 focus of this Quality Systems Engineer II position will be supporting the Corrective and Preventive Action (CAPA) process at access Solutions, including nonconforming events, and ensuring compliance to CAPA processes, Medical Device regulations, and Quality System requirements. As a member of the Quality Systems team, this individual will support department, site, and global level initiatives and will maintain a strong collaborative partnership with multi-functional teams while contributing to the overall health, including the suitability, adequacy, and effectiveness, of the CAPA process.

Your responsibilities will include:

• Mentoring cross-functional CAPA teams on:
  • Root cause analysis, corrective action plans, and effectiveness verifications
  • Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet critical CAPA phase timelines
  • Creating robust, compliant, and timely records, using the electronic CAPA database system
• Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements
• Applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues
• Acts as an effective team member and/or leader in supporting quality disciplines, decisions, and practices
• Being part of a team of subject matter experts in matters relating to CAPA at the site and providing guidance on how to best apply the processes efficiently, effectively, and compliantly
• Determining and tracking actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects
• Support other projects as needed.

Required qualifications:

• Bachelor’s degree in Engineering required
• 2+ years of experience in a medical device manufacturing setting, within quality or regulatory/compliance environment
• Knowledge of basic Quality System Requirements and Good Documentation Practices
• Experience working with nonconforming material and/or CAPA methodologies/systems
• Attention to detail, strong technical writing and documentation skills, and the ability to prioritize tasks effectively in a deadline-driven environment
• Strong communication skills (written and verbal), e.g. comfortable speaking and presenting to different levels of management and cross-functional stakeholders.

Preferred qualifications:

• Bachelor’s degree in Science or Engineering
• 2+ years of experience in Quality Systems and/or CAPA management
• Detailed understanding of quality system requirements as stated within FDA Quality System Regulation 21 CFR Part 820 and ISO 13485
• Hands-on Project Management experience
• Able to work independently and as a contributing team member
• Continuous improvement mindset with a passion for Quality

What we have to offer:

• Hybrid working model for many roles combining on-site and remote work, paired with flexible working hours.
• Comprehensive total rewards package, including bonus, RRSP or 401k employer matching, tuition reimbursement, health & dental benefits, and a health or lifestyle (your choice!) spending account.
• Generous paid time off, including vacation days, personal days, statutory holidays, and a Holiday shutdown!
• A strong commitment to mental health and well-being, including a company-paid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionally-led classes for all employees.
• Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wi-fi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks
• Employer subsidized gourmet, high-quality, healthy meals available onsite, freshly delivered multiple times a week.
• Strong senior leadership commitment to Inclusion and Diversity; many opportunities to join I&D committees and spearhead I&D initiatives; employer-hosted roundtables with external experts, guest speakers and workshops/celebrations.
• Formal mentorship program, robust biweekly internal networking events and multiple communication streams open to senior management for all employees to provide continuous feedback
• Employee-friendly work environment, with opportunity to participate in employee-led clubs (for example, book club, French club, gardening club, rock climbing club, boardgame club, tea club), and support to create new clubs
• Employee recognition rewards platform (Guusto) – receive gift cards as recognition for a job well done!
• Formal leadership training programs for leaders and non-leaders to develop their careers
• Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
• Smart commute options including complimentary shuttle from Kipling Station, subsidized transit program and complimentary Electrical Vehicle charging on site.

Requisition ID: 562121

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!