- Reference: CJ43788x
- Job Type: Permanent
- Location: Limerick, Limerick City, Munster
- Category: Production
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
- Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
- Analysis and review of concession requests.
- Review and approval of change management activities.
- Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
- Support execution and analysis of QATs.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
- Proficiency in statistical methods and application.
- Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
- Assist in the development, responsible for review & approval of process and equipment validation/qualification.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
- Coach and mentor others in quality topics and activities
- Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or a Masters of Science, Engineering or related subject
- Previous experience in a regulated environment desirable.
- Proficient in understanding of Med Device manufacturing processes desirable.
- Familiarity with ISO 13485, GDP, GMP desirable.
- Lean Six Sigma training a distinct advantage.
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and quality practices & methods.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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