Our client based in Roscommon is looking to hire a Quality Assurance Engineer.
The Role:
Reporting to the Quality Engineering Manager, the Quality Assurance Engineer will provide ongoing Quality support in an effort to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production.
Responsibilities:
* Adhere strictly to company policies and procedures.
* Extensive understanding of products and processes within area of responsibility.
* Thorough knowledge of all Production processes and quality management systems.
* Conform to the requirements of the Quality and Environmental Management System.
* Review, update and maintain existing quality management processes and procedures.
* Maintain detailed and accurate quality records, data analysis and documentation.
* Raise Quality profile and operating standards within the business.
* Deliver on all KPIs that help the business achieve its goal.
* Support projects and initiatives across the plant where required, ensuring key deliverables are achieved in a timely manner and liaising effectively with internal and external customers.
* Initiate and drive continuous improvement opportunities/programs.
* Lead and drive QA initiatives within area of functional responsibility.
* Represent quality interests and concerns on project teams.
* Quality support within the assigned Customer and/or project teams to ensure Customer and QMS requirements are implemented and fulfilled to required GMP standards.
* Lead Quality Engineering activities for the introduction of new product lines through development of product inspection plans, production documentation, process FMEAs and risk management plans.
* Ensure that products meet customers’ quality and product integrity requirements and continually seek to identify and drive improvements in product and process quality.
* Lead and coordinate/execute process and product validations.
* Provide quality input to cross functional team to support existing product lines with an ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
* Ensure quality standards are adhered to, and all production processes are carried out according to procedures.
* Investigate root cause of quality issues and follow through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
* Oversee non-conforming material, customer complaints, CAPA investigations, analysis, and improvement.
* Utilize data analysis and trending, statistical process control, root cause analysis and implement corrective actions.
* Utilize DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation.
* Ensure quality inspection instruments are accurate and regularly calibrated, tested and audited.
* Assist with ensuring that the Company retains ISO accreditation.
* Conduct internal audits and external audits as required.
* Host audits of the Company’s operations by external bodies (e.g., audits from customers, FDA, audits relating to certification to official standard e.g., ISO 13458).
Requirements:
* Level 8 or equivalent Degree in Quality Assurance or similar discipline.
* Minimum of 3 years’ experience in a Quality Engineering role with active involvement within a manufacturing floor, preferably in the medical device sector.
* Effective communicator and influencer across multi-functional teams, with the ability to manage internal and external customers’ requirements.
* Proficient with Syspro, Minitab & Lotus Notes, is desirable.
* Knowledge of ISO 13485, ISO 14971 and QSR 21 CFR Part 820 standards.
* Excellent interpersonal skills.
* Ability to work in a cross functional team.
* Strong proficiency in statistical analysis techniques to investigate and solve problems and improve quality.
* Ability to plan, organise, and prioritise own daily work routine to meet established schedule.
* Ability to drive projects to completion.
* Project Management training is advantageous.
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