Spécialiste de la qualité II/Quality Specialist II

Onsite Location(s):

Montreal, QC, CA

Additional 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 Quality Specialist II will provide Quality Engineering support to R&D activities and assist in site improvement efforts. This includes generation, analysis, and compilation of required metrics and presentations to support Quality Systems and Engineering requirements. In addition, the successful candidate will assist in the execution of projects designed to improve the compliance, efficiency, and effectiveness of assigned quality systems.

Your responsibilities will include:

1. Coordinate and maintain Quality system data to assist senior leaders in making critical assessments of the health of the quality system.
2. Create summary presentations of the analysis for review by a variety of key stakeholders.
3. Work with QA and R&D to identify areas within the quality system and design assurance in need of improvement and execute NCEPs and Corrective and Preventive Actions as appropriate.
4. Assist in the Quality Systems and Design Assurance portfolio management by monitoring, tracking, and providing data to management around the quality system for review in templates and presentations.
5. Provide data to project/department managers on the status of project metrics for their assigned project including tracking milestones, budget attainment, and other relevant metrics.
6. Prepare new and revised documents for routing per the local document approval process. Track progress in obtaining approvals for document change notices to aid in timely approvals.
7. Incorporate documentation edits and update all logs associated with documentation status. Release approved documents and notify affected personnel of changes impacting functional areas.
8. Suggest changes to processes documentation and training programs in the spirit of continuous improvement.
9. Support teams in implementation of quality systems upgrades.
10. Monitor and document compliance with the local training program to ensure training compliance.
11. Manage the biennial review of the documentation system to ensure compliance with standards.
12. Conduct internal audits as needed and support regulatory, notified body, and corporate external audits.
13. Interact between functional groups regarding Document Change Notices.
14. Facilitate Document Review meetings and make recommendations as needed to functional areas.
15. Support quality-related needs of various departments and processes, including Design & Development and Non-Device Software & Equipment Controls. This includes validation documentation and quality planning support.
16. Perform Root Cause Analysis of system/product non-conformances as discovered by Manufacturing, Customers, and Internal and External audits.
17. Support the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
18. May actively participate in New Product Development, Design Review, and Design Control Activities.

Required qualifications:

1. Undergraduate or master's degree in a science, business, or related field.
2. 2-4 years of relevant experience in a quality-related role.
3. Experience in a regulated industry (i.e., pharmaceutical, automobile, aerospace, etc.)
4. Strong documentation and writing skills.
5. Excellent attention to detail.
6. Requires minimal supervision.
7. Willingness to learn and grow within the Quality Organization.

Preferred Qualifications:

1. Engineering or Health Science related degree.
2. Experience with ISO 13485.
3. Internal Auditor Certification.
4. Quality Management Certification.

Requisition ID: 604312

Minimum Salary: $57200

Maximum Salary: $113700

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.

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!