Boston Scientific Senior Quality Engineer - Electrophysiology 

Canada, Ontario, Mississauga 

456751446

Your responsibilities will include:

• Provide Quality Engineering support for the Design Assurance team.
• Navigate government regulations and standards, including 21 CFR 820, ISO 13485 and ISO 14971.
• Develop, modify, and maintain quality system (QMS) requirements.
• Collaborate with engineering and other functions to ensure quality requirements are met.
• Collaborate with Research & Development (R&D) Engineers to update Design History Files (DHFs) and meet new requirements.
• Provide quality and compliance input to project teams for project decisions and deliverables, especially those related to risk.
• Provide training to affected members of the organization when new or updated quality system requirements are released.
• Provide guidance to other team members on common projects.
• Support internal and external audits as required.

Required qualifications:

• Bachelor’s degree in engineering required.
• 4-5 years of medical device experience, or advanced degree with a minimum of 3 years medical device experience.
• A strong understanding of medical device design controls.
• Must be a critical thinker and active listener with good time management skills.
• Self-starter with the ability to quickly learn about new processes.
• Excellent analytical and communication skills (written and oral).
• Ability to work effectively within a team and across functions.

Preferred qualifications:

• Experience working in a quality role at a medical device company.
• Experience working with PLM (Windchill) and ERP (MES and/or SAP) software
• Experience with quality system integration.
• Experience with DHF remediation projects.