Quality Systems Engineer I

at  Boston Scientific Corporation

QUALIFICATIONS:

• Level 8 degree qualification in engineering or science2-3 yrs quality experience in a GMP environment.
• 
  Requisition ID: 582793
  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: Systems Engineer, Quality Engineer, Engineer, Engineering, Qualit

ABOUT THIS ROLE:

The Quality Systems Engineer will establish and maintain effective quality system structures to ensure consistent implementation of quality systems at Boston Scientific Clonmel. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards (LRGS).Provide support to customer as required helping to ensure delivery of highest quality product.

RESPONSIBILITIES:

• Implementation of internal requirements and external laws, regulations, guidance and standards as applicable to quality systems.
• Familiar with internal requirements and external regulations and standards and incorporate into requirements for use in Boston Scientific business processes. Support External Inspections as required.
• Identify areas of potential noncompliance or improvements by conducting Internal Audits to Schedule.
• On going review and update the Quality System procedures.
• Educate functional areas on quality system requirements.
• Participate cross functionally and across business units to standardize Boston Scientific Quality System policies and procedures.
• Collect/Provide business/quality system process data from different parts of the company for analysis.
• Act as an expert resource in external regulations and standard requirement knowledge for cross functional teams
• Support the site corrective and preventive actions process as site mentor.
• Act as an expert resource to support the containment function on site to prevent the unintended movement of product or components. May be required to provide support to other sites in this area of responsibility also.