Title:  Senior Quality Engineer - Validation

Job Summary

In this role, you will Report to the NPI Senior Quality Manager or Quality Work Package Manager this role will support NPI projects with key focus and responsibility around the interpretation, application of and compliance to the FDA’s Code of Federal Regulations (QSR’s, and cGMP’s), ISO 13485, agreed specification, validation master plan and customer requirements. This person will provide the company with the technical, and quality resources to manage the quality on selected  NPI projects. In particular to coordinate the necessary activities for ensuring the timely closure of internal/external quality issues / projects, ensure the timely and effective closure of internal/external quality issues and to coach and drive a culture of compliance and continuous improvement.

Essential Duties and Responsibilities

• Program Activities:
  • Reporting on project progress, identifying successes, driving compliance via validation master plan (VMP) / customer specification. Escalated to the Program Manager / Quality Manager as required.
  • Responsible for the introduction of quality requirements of new or transferred products into West.
  • Ensure that programmes are introduced  to West in a manner that is in compliance with the appropriate regulatory requirements, customer specification and consistent with West Quality Management Systems (QMS)
  • The generation of a responsibility assignment index (RACI) and the update of same.
  • Support the suppliers selection process in accordance with West supplier management procedures and that confidentiality disclosure agreements (CDA’s) are in place with service provides as required.
  • Metrology data review and reporting to the team during OQ & PQ.
  • Key quality contact on all quality issues with the customer, host Quality & technical forum’s and face-2-face meetings with the customer.
  • Management of customer documents into the West Quality system i.e. drawings, specifications, quality agreements etc. and the training out of relevant personnel.
     
• Risk Management:
  • Responsible for the generation of a Risk Management Plan (RMP) for the project covering quality, supplier chain, timeline and commercial risks.
  • Facilitate equipment failure, mode and effects analysis (FMEA) and ensure with the Program Manager that the subject matter expert (SME) is trained to and updated the relevant FMEA as required
  • Facilitate risk assessments as required to ensure continuing compliance, safety and quality of our processes and products
  • Initiate the project risk register and ensure that this is maintained and updated by the program manager or designee
  • Responsible for the generation of a Risk Summary Report (RSR) prior to the completion of the validation summary report 
     
• Validation Activities:
  • Generation of the VMP and defining the documentation path the project will take
  • Review and approval of validation documentation (protocols & reports)as a compliance review against the signed off VMP and customer requirements
  • Generating, communicate and updating the document tracker.
  • Ensure the archiving and filing of validation documentation associated with the project
  • Generation of Validation summary report (VSR) post project completion.
  • Metrology Activities:
  • Support the initiation and completion of the QFD (Quality Function Deployment) in a timely manager
  • Support timely analysis of metrology data at the various stages of the validation life cycle to support decision on process / tooling adherence or further investigation required.
     
• QMS Activities:
  • Drive the close out of change control, deviations, quality continuous improvement identified during the project.
  • Solve in conjunction with the appropriate department customer related problems / issues as required
  • Drafting of the defect library and QSS during OQ with formal hand over to Operational Quality prior to PQ
  • Implement best practices principles into West QMS as applicable.  
  • Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits.
  • Facilitation and supporting the completion of the pre-PQ checklist.
  • Review of quality documents to drive compliance i.e. batch records, material reviews reports, project protocols and reports

Basic Qualifications

• Must have a third level qualification in Engineering/Quality/Science.Must have a minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the medical device / pharmaceutical sector.
• Must have an in-depth knowledge of validations in a medical device environment.
• Must have a thorough understanding of statistics, SPC, and ideally the use of minitab.
• Must have excellent communication skills both oral and written.
• Must be able to prioritize and organise tasks.

Preferred Knowledge, Skills and Abilities

• A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.