Quality Systems Engineer I
Boston Scientific
- Clonmel, Co Tipperary
- Permanent
- Full-time
Additional Locations: Ireland-Cork; Ireland-Clonmel; Ireland-GalwayDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 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.
- Level 8 degree qualification in engineering or science
- 2-3 yrs quality experience in a GMP environment.