- Reference: CJ43787
- Job Type: Permanent
- Location: Cork
- Category: Production
Provide quality engineering support 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, with moderate supervision and mentoring, 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.
- Approval of NC, builds proficient in problem solving and root causing activities.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Review of change management activities.
- Maintain KPIs 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, familiarity in the science of Human Factor identification, reduction and mitigation.
- Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
- Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
- Developing proficiency in statistical methods and application.
- Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
- Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
- Support manufacturing transfers to other plants/facilities, execution quality activities.
- Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
- Masters or Bachelor of Science, Engineering or related subject
- Previous experience in industry desirable
- Understanding of Med Device concepts desirable.
- Familiarity with ISO 13485, GDP, GMP concept desirable.
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and quality concepts / theories.
- 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 firstname.lastname@example.org
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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