JOB TITLE: Quality Assurance Engineer
LOCATION: Castlerea, Roscommon (On site)
BENEFITS: Good salary, 5% bonus, Healthcare and pension



SUMMARY:
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. Scope of role will also include addressing any customer and internal related issues identified in the manufacturing process and validation of new processes/products ensuring effective implementation of the required QMS documentation.



RESPONSIBILITIES:
- Extensive understanding of my clients 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.
- 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.
- 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 change requests are effectively managed.
- Lead Quality Engineering activities for existing product lines through maintenance and continuous improvement of product inspection plans, production documentation, process FMEAs and risk management plans. Ensure change requests are effectively managed.
- Ensure that products meet Harmac's and 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.



REQUIREMENTS:
- Level 8 or equivalent Degree in Quality Assurance or similar discipline.
- Minimum of 2 years’ experience in a Quality Engineering role with active involvement within a manufacturing floor, preferable in the medical device sector, is desirable.
- Guided by the disciplines of due diligence and compliance in all aspects of work.
- To be a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives.



Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie