Acting as a Quality Lead for all phases of production realization including NPD, NPI, Commercialisation, Sustaining, End to Life.
1. Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
2. Trouble shooting quality issues identified during product development and commercialisation and driving solutions to reduce non-conformances.
3. Quality input and guidance on Validation planning and documentation utilising risk-based (pFMEA) decision making and driving risk mitigation activities into process development and product quality assurance.
4. Quality lead on vendor and part appraisal and approval processes.
5. Quality lead on process change and related assessment and implementation of change notification.
6. Working with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes.
7. Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specifications, and drawings are in place and being adhered to during product development, manufacturing transfer, and commercialisation.
8. Ability to understand and lead specification reviews, factoring in Company capabilities, and drive alignment with customer on acceptance criteria ensuring Company and Customer specifications/drawings are aligned. Drive for reduction or elimination of variation from processes and inspections.
9. Ensuring that all design/specification/process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management.
10. Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule.
11. Establish and monitor process quality performance to determine when improvement actions are appropriate.
12. Key driver in responding to and acting on Customer quality feedback and requests.
13. QE review and sign off on QMS documentation and records.
14. Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area.
Contract details:
1. 6-12 month contract (likely to be extended or go permanent)
2. Full time hours
3. Starting ASAP
4. 3 to 5 days per week on site in Limerick
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