Posted on Aug 19, 2019 by Red - The Global SAP Solutions Provider
Quality Engineer/1 year/Cork/Start ASAP
Job Purpose and primary objectives:
Work as an Engineer/Consultant in the client team delivering best in class solutions and services to our clients.
The job holder will lead the QA element of process/technological improvements, new product introduction and product transfers in conjunction with local Quality, Operations and R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
1. Represent Quality as part of a cross functional team to ensure delivery of projects (NPI's and Technology) into production with the highest level of quality, compliance, and adherence to timelines
2. Compile and execute validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material.
3. Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
4. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
5. Liaise with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
6. Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
7. Lead QA input to Design for Manufacture activities on site.
8. Ensure daily and project compliance with all Documented Quality systems ie FDA QSR's and ISO 13485/9001 requirements etc. during all day to day
9. Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
10. Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
11. Assist in the development, review and approve product, gauge, tooling and fixturing drawings.
12. Maintain a good level of house-keeping in designated areas and observe all Health and Safety at work requirements
1. Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills.
2. Flexible work ethic.
3. Strong influencing skills.
4. Excellent communication skills (written and oral).
5. Problem Solving skills - to assist in maintaining project progress and on design issues.
6. Decision Making - required to make decisions on technical issues.
7. Degree of responsibility - must be capable of taking direction and taking responsibility and ownership for systems.
8. Excellent planning & organisation skills.
9. Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
10. Continuous Improvement Focus
1. A degree level or similar qualification in mechanical or industrial engineering is preferable.
2. Basic experience in a quality role within a regulated industry.
3. Proven ability to successfully introduce new product development in the Medical Device Industry.
4. Proven knowledge and ability regarding product verification and process validations.
5. Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
6. Proven experience and training in Mechanical Engineering processes