BONUS, CAR PARKING, PAID HOLIDAYS, PENSION / PRSA, VHI
Process Quality Engineer - North Dublin.
Our client seeks a Process Quality Engineer with experience in product & process quality, including new product introduction. This is an excellent opportunity to work in a leading healthcare manufacturing facility. The quality function works cross-functionally with engineering, production & procurement to cover a wide area of responsibilities such as CAPA, Non-Conformances, Deviations, Inspections/ Regulatory Audits, Complaint Handling, Validation, Verifications, Risk, Product Release.
In this role you will report to the QA manager & be a member of the site QA team collectively responsible for maintaining & improving Quality & Compliance in the manufacture & support of products & services.
As a member of the quality team work collaboratively with cross- functional stakeholders (engineering, production & procurement) creating & ensuring that value-streams comply with QMS requirements & production targets.
You should be experienced in QMS covering a broad range of activities including process line support, non-conformance process management, risk assessment, CAPA, equipment & manufacturing process validation. You should have demonstrated strong competencies & leadership to drive fast-paced change in all or some of these areas.
As a member of the site Quality team you will own & be responsible for processes over multiple product lines & value streams.
You will focus on & be responsible for leading Quality system process improvements, updating procedures & overseeing their timely implementation to achieve both fully compliant & leaner processes. This will include leading & supporting initiatives to digitise & streamline processes.
You should ideally be experienced in the use of digital data analysis & measurement techniques to identify opportunities for process improvement.
Using lean tools, own & lead quality projects that deliver quality, cost & process improvements.
Design transfer supporting New Product Introduction
Support activity in identifying potential opportunities in the existing quality control system & ensure processes for new products have improvements in place.
Assess manufacturing capability to meet quality requirements based on digital data analysis & internal audit. As a follow-on activity create concise reports that enable project teams to implement improvements & corrective actions.
Support the process of generating pFMEA & work instruction documentation for internal manufacturing processes.
Support design transfer activity & own responsibility for review & approval of plans & reports ensuring they meet regulatory & technical standards, guaranteeing new equipment/process is fit for purpose & commissioning records are correctly documented.
Qualifications & Experience:
Minimum of Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science)
Minimum 5 years' relevant experience in a regulated environment with a core appreciation of FDA regulations.
Strong leadership skills & ability to influence cross-functional teams to drive work scopes to completion.