- See description
- Permanent full-time
- Updated 17/02/2017
- Sara O'Riordan
Our client is one of the world's leading medical technology companies and together with their customers, They are driven to make healthcare better. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology products to help people lead more active and more satisfying lives. It provides products and services to over 100 countries.
- 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 Quality Audit Tracking.
- Advocate of Human Factor practices, familiarity in the science of Human Factor
- 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.
- Self-starter with efficient work style and ability to handle multiple tasks in a fast paced environment.
- Problem solving and analytical skills