AddressAdditional Locations: Canada-QC-Montreal
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 Design Assurance Quality Manager will lead a team of pre-market and post-market Design Quality Engineers to ensure safe and compliant development and commercialization of complex technologies and products.
Your responsibilities will include:
- Manages, coaches, leads, and mentors cross-functional team members in the application of the Design Control, Risk Management, and Post-Market Surveillance requirements for EP products.
- Builds and maintains an inclusive, diverse, and high-performing culture.
- Demonstrates expert knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance.
- Work with cross-functional teams to implement business continuity, cost reduction, and field improvement-related projects.
- Represent the division on various global quality system improvement projects by proactively soliciting input from stakeholders, reviewing proposals to assess impact on EP, and advocating for EP needs amongst global counterparts.
- Owns and drives independently quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams.
- Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Post Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.
- Ensures compliance with all Corporate and applicable regulations related to complaint investigation management.
- Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers, and assists teams with response writing for product and quality system-related questions.
- Supervise and provide support to the Design Quality Assurance team in activities related to PDP projects.
- Assist and lead the team with engineering evaluations/generation and updates of procedures.
- Improve systems and procedures from the Design Quality area.
Required qualifications:
- Bachelor’s degree in a STEM-related Field.
- Experience in managing regulations and complaints MDR / MDD.
- Experience with design controls, risk management, and post-market surveillance.
- At least 6 years of experience in a similar position.
Preferred qualifications:
- Master’s degree in an engineering, business, or regulated industry field.
- Formal training on statistical and quality techniques and ASQ Certified.
- Experience managing technical teams.
Requisition ID: 579114
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!
