Senior Quality Engineer

Boston Scientific
Posted on

Type

Executive / senior industry position

 

Act as a member of the Boston Scientific Cork facility quality team.  To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

 

  • Supervision of Quality Technicians and Quality Engineers.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Approval of analysis reports and analysis of complaint trends.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Transfer and implement product and processes from development or from another manufacturing facility.
  • Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.

 

  • Excellent interpersonal and communication skills with good leadership abilities.
  • Ability to work as part of a team and meet targets/goals efficiently.
  • Excellent analytical and problem-solving skills.
  • Minimum of 4+ years’ experience within the medical device or pharmaceutical manufacturing industry - people management experience an advantage.
  • Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

 

 

 

More Information

Posted on

Type

Executive / senior industry position

Cork%2C%20Ireland

Cork , Ireland