Our client, a leading medical device company in Roscommon, is looking for a Quality Assurance Engineer to join their team.
Reporting to the Quality Engineering Manager, the Quality Assurance Engineer will provide ongoing Quality support to maximize production quality performance, including identifying root causes and implementing corrective/preventive actions on all quality issues in production. The scope of the role will also include addressing any customer and internal related issues identified in the manufacturing process and validating new processes/products, ensuring effective implementation of the required QMS documentation.
Job Responsibilities will include but are not limited to the following:
* Adhere strictly to company policies and procedures.
* Extensive understanding of products and processes within the area of responsibility.
* Thorough knowledge of 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 the area of functional responsibility.
* Represent quality interests and concerns on project teams.
* Provide 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 the development of product inspection plans, production documentation, process FMEAs, and risk management plans.
* 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 that products meet the Company 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 teams to support existing product lines with the ability to multi-task and to work in a high-paced environment.
* Ensure quality standards are adhered to, and all production processes are carried out according to procedures.
* Investigate root causes 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.
* Ensure quality inspection instruments are accurate and regularly calibrated, tested, and audited.
* Assist with ensuring that the Company retains ISO accreditation.
* Conduct internal and external audits as required.
* Train Graduate and Junior Quality Engineers on policies and procedures and perform an active role in their development and growth.
* Familiarize yourself with a variety of processes to allow you to work across a number of product lines.
* 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.
* To be a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
* Effective communicator and influencer across multi-functional teams, with the ability to manage internal and external customers’ requirements.
* Proficient with Microsoft Office.
* 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, organize, and prioritize own daily work routine to meet established schedule.
* Ability to drive projects to completion.
* Project Management training is advantageous.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
Pale Blue Dot Recruitment
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