Boston Scientific Quality Engineer II 

Canada, Ontario, Ottawa 

218790587

About the role

You may be suited for this role if you can easily transfer and apply knowledge learned from one area to another. What truly makes you stand out is your attention to detail and affinity for creating structure and simplicity in documentation and processes.

*Please note, for Canadian applicants without professional engineering designation (P.Eng), the title of this role is amended to “Quality Engineering Analyst II” to follow provincial laws.

Your responsibilities will include:

• Track/trend service provider performance to establish thresholds for action.
• Dispositioning raw materials.
• Work with internal stakeholders to obtain relevant information required to investigate quality events.
• Liaise effectively between external service providers to drive quality events to resolution.
• Aid in development of quality documentation, including manuals, policies, procedures, work instructions and forms.
• Writing of quality documentation, including manuals, policies, procedures, work instructions and forms.
• Support in internal and external regulatory audits.
• Other duties as assigned.

Required qualifications:

• Bachelor's Degree in Science or Engineering or relevant and progressive work experience in lieu of degree (Minimum of 8 years’ experience in GMP environment)
• 1-3 years of relevant work experience in the medical device industry, directly supporting Quality Management Systems and documentation
• Knowledge of ISO 13485, MDSAP, ISO 9001, ISO 11607, and/or AIMDD/EU MDR
• Ability to travel domestically and/or internationally up to 10%.

Preferred qualifications:

• Works well with diverse personalities.
• Highly organized
• Effective time-management skills
• Critical thinking
• Resourcefulness