Quality Engineer II

at  Boston Scientific Corporation

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 thinkingResourcefulness
• 
  Requisition ID: 585975
  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!
  Job Segment: Medical Device Engineer, Quality Engineer, Compliance, Medical Device, Engineering, Legal, Healthcare, Qualit

ABOUT THE ROLE

At Boston Scientific, we improve the quality of our products and processes to drive improvement in patient outcomes. We are looking for a Quality Engineer* II (QE II) to drive the build out our local management systems to support compliance and product quality. This role brings together a blend of operational/supplier quality with quality systems design and is listed as 1-year contract, with the possibility of extension.

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.