Quality Engineer III
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.
About the role
This role offers an individual the opportunity to be part of the Access Solutions Complaint Investigation Site within the Post Market Quality Assurance team at Boston Scientific. The primary activity for this role is to complete product analysis for investigations of field complaint allegations against Boston Scientific products. This position is a vital part of improving patient care by ensuring Boston Scientific device allegations are investigated efficiently and effectively.
Your responsibilities will include:
- Applying mechanical and electrical engineering to complete investigations and review/approve returned product analysis results to ensure field allegations are adequately addressed in a timely manner.
- Strong understanding of manufacturing processes and controls to aid in detection of potential manufacturing non-conformances leading to complaint allegations from the field.
- Partnering with manufacturing counterparts in Quality and Process Engineering teams to collaborate on investigations and correction/corrective actions related to device manufacturing. This will require strong communication skills with both manufacturing teams in Canada and Costa Rica.
- Own and support root cause analysis and initiation of correction and corrective actions through non-conformance evaluations when escalation to the correction and corrective action processes is a result of complaint trends in the field (ie. CAPA).
- Applying risk management and root cause analysis tools to determine the cause of emerging product issues and the impact these product non-conformities could have on patients and users.
- Focusing on continuous improvement by championing and fostering the execution of internal and global projects within the Post Market Quality department.
- Fostering a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Support other activities within in the Complaint Investigation Site as needed, such as, brainstorming and decision making for field actions, communicating product quality issues to Sr. management, etc.)
- 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.
- Occasional short-term travel outside of Canada
Required qualifications:
- Bachelor's Degree in Engineering
- 3-5 years of relevant work experience, including experience in manufacturing quality or process development
- Demonstrates critical thinking and problem-solving capabilities
- Strong communication skills, with the ability to establish impact and consequences
- Ability to collaborate and influence across multiple, cross-functional teams
Preferred qualifications:
- Degree in Mechanical or Biomedical Engineering
- Understanding and working knowledge of Medical Device Quality Systems and Regulatory Requirements
- Clinical knowledge of cardiology procedures
- Experience in the medical device industry
- Continuous improvement and Six Sigma experience
Requisition ID: 610953
Minimum Salary: $66500
Maximum Salary: $131800
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for hourly, non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for salaried, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
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!
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