- Reference: GY43070
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
Duties and Responsibilities
- Ensure that Production operations are completed in accordance with the requirements of the quality system and ISO13485:2003.
- Ensure all customer requirements are identified, documented, understood and met.
- Document manufacturing procedures, routes, purchasing specifications, inspection procedures and standards etc. Approve all updates to same.
- Oversee the execution of validation activity as required. Review and approve Master Validation Plans, FMEAs, IQ/OQ/PQ protocols and reports for product and process changes, new equipment and process improvement activities.
- Drive improvement in product quality, as measured by reduced customer complaints and increased product yields.
- Advise customers of proposed changes to processes / products / vendors etc. Overview the testing etc. required ensuring proposal has no effect on product.
- Perform internal audits as per agreed schedule and prepare for external audits.
- Review line issues and work with the team in implementing effective and timely resolutions.
- Ensure effective and timely resolution of Production related CAPA’s.
- Review customer requests/complaints related to Production parts. Ensure robust solutions are implemented.
- Keep your skills current and be conversant with the latest developments in technologies and materials which are relevant to the Company’s business.
- Participate in improvement activities, including Kaizen events, ensuring that quality requirements are followed during the change implementation process.
- Function within a team environment and communicate information effectively to all stakeholders.
- Keep your skills current and be conversant with the latest developments in technology and materials which are relevant to the Company’s business.
- To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
- Degree qualification in Engineering / BSc / Quality Systems OR significant relevant experience in a quality assurance role within the Medical Device Industry.
- A minimum of 5+ years’ experience in a similar role in the Medical Device / Component Industry.
- Excellent communication skills both verbal and written.
- Excellent Administrative skills.
- Ability to manage several tasks simultaneously.
- Excellent attention to detail.
- A positive attitude to dealing with people
For a confidential discussion and more information on the role/company please contact Amy O’Neill on 091-706718 or email email@example.com
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