Apply now »

Senior Quality Engineer

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Mississauga, ON, CA

Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto

 

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.

 

Overview

The Senior Quality Engineer works closely with development teams to ensure quality requirements are met.

 

Snapshot of Responsibilities:

  • Follow all Quality System Practices as defined by Access Solution’s practices, policies, and Standard Operating Procedures to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable.
  • Develops, modifies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Devises and implements methods and procedures for various functions such as inspecting, testing, and evaluating the precision and accuracy of products and product development activities.
  • Designs or specifies inspection and testing mechanisms and equipment; reviews quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Lead quality initiatives in support of development for technological systems, customized/off the shelf components and software applications.
  • Provide guidance regarding quality integration strategies and approaches to assessing Design Control related documents and records for potential compliance gaps; provide in-depth and complex data/problem evaluation and analysis.
  • Collaborates with engineering and manufacturing functions to ensure compliance with company policies, procedures, and quality standards.
  • Interface with key functional areas to obtain necessary information and documents required for the development of Verification and Validation Plans & Reports.
  • Applying advanced analytical skills by evaluating both qualitative and quantitative data including synthesizing large data sets by identifying key themes/information.
  • Other duties as required.

 

 What you bring to the team: 

  • Bachelor’s Degree in Engineering required
  • 5+ years of work experience in regulated industry
  • ASQ-CQE, CQA or equivalent certification is an asset
  • Experience with medical device design control and risk management.
  • Familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
  • Familiar with the use of tools such as Six Sigma, Kaizen, and Reliability Analysis
  • Ability to effectively support multiple high priority deliverables in parallel
  • Strong written and verbal communication skills
  • Demonstrated attention to detail
  • Ability to travel if required (US)

 

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.

 

About Us
Baylis Medical and Boston Scientific recently announced the close of Boston Scientific’s acquisition of Baylis Medical Company Inc. The integration of Baylis Medical into Boston Scientific is ongoing and our Mississauga locations will collectively be referred to as the Global Access Solutions site.

 

From Joe Fitzgerald, EVP and President of Cardiology at Boston Scientific:

 

"The close of this acquisition allows Boston Scientific to integrate the Baylis platforms with our existing electrophysiology and structural heart offerings, further strengthening our position within the highest growth cardiology markets. We are now the only company to pair a comprehensive access portfolio with existing left-heart therapies such as left atrial appendage closure and atrial fibrillation ablation, providing physicians with a complete toolbox to treat patients with safety, efficacy and efficiency."

 

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com.

 

We are looking for talented individuals, like yourself, to join us and make an impact in the lives of patients. Are you ready to join us?

 

We are an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process

 

While we thank all applicants, only those being considered for an interview will be contacted.

 

Want an inside look at careers and life with us? Follow us on LinkedIn and Instagram!

 

Requisition ID: 557560

 

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, Senior Quality Engineer, Medical Device Engineer, Risk Management, Counseling, Engineering, Finance, Healthcare

Apply now »