Description
I have an immediate opening for a Quality Engineer (Development) with a leading medical device company based in Dublin. This is an excellent opportunity to join a company who are embarking on a major expansion plans and offer excellent opportunities for career progression.Summary:
* To support NPI projects with 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 and metrology deliverables on selected NPI projects.
* 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.
* Coach and drive a culture of compliance and continuous improvement.
Requirements:
* Must have a third level qualification in Engineering/Quality/Science.
* Must have a minimum of 2 years' experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
* A thorough working knowledge of quality systems such as ISO CFR Part 820 is essential. Knowledge of 21 CFR Part would be considered an advantage.
* Must have an in-depth knowledge of validations in a Medical Device environment.
* An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems
* Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
* Must have excellent communication skills both oral and written.
* Auditing experience to the requirements of ISO CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.
* Must be able to prioritize and organise tasks.
Essential Duties and Responsibilities:
Validation Activities:
- Generation of the Validation Master Plan (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
Program Activities:
- Reporting on project progress, identifying successes, driving compliance via VMP / customer specification. Escalated to the Program Manager / Quality & Regulatory Manager as required.
- Responsible for the introduction of quality requirements of new or transferred products into the business.
- Ensure that programmes are introduced in a manner that is in compliance with the appropriate regulatory requirements, customer specification and consistent with QMS
- The generation of a RACI and the update of same.
Risk Management:
- Responsible for the generation of a Risk Management Plan (RMP) for the project covering quality, supplier chain, timeline and commercial risks.
- Facility equipment FMEA and ensure with the Program Manager that the SME is trained to and updated the relevant FMEA as required
- 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
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 during OQ with formal hand over to Operational Quality prior to PQ
- Implement best practices principles into company's QMS as applicable.
- Support internal and supplier audits. Play a key role in the preparation and hosting of third party and customer audits.
This is an excellent opportunity to join a rapidly growing medical device company based in Dublin. If you are interested in hearing more please apply directly to this advert or contact Derek Sheridan on on for immediate consideration.