Our client, a medical device company in Cork are looking to recruit a Senior Mechanical Engineer for their site on a contract basis
- Reporting to the QA Technical Leader the Quality Technology Transfer Engineer shall lead from a Quality perspective.
- 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 company R&D personnel ensuring timely communication to all stake holders to effect successful project completion.
Main Duties & Responsibilities:
- 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
- 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.
- Use of statistical analysis as part of validation activity and defining subsequent inspection and controls in production
- Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Liase with R & D to ensure Critical to Quality Characteristics are agreed and documented for all New Product Development
- Lead Design for Inspection activities for all New Product Introduction to ensure latest technology is available to reduce Human Error.
- Lead QA input to Design for Manufacture activities on site.
- Ensure daily and project compliance with all Documented Quality systems i.e. FDA QSR's and ISO 13485/9001 requirements etc. during all day to day
- Provide technical assistance to carry out problem analysis/complaint investigation as required and define through negotiation effective corrective actions.
- Assist in problem solving for new products and established production process enabling reduction in compliance risks, scrap and reprocessing.
- Assist in the development, review and approve product, gauge, tooling and fixturing drawings.
- Maintain a good level of house-keeping in designated areas, and observe all Health and Safety at work requirements.
Key Competencies Required
- Culturally aware
- Team player
- Good influencing skills
- Project Management skills
- Good generalist (experienced quality person)
- Defuser, not inflamer
- Good communicator
- Politically sensitive
- Travel Flexibility
Qualifications & Experience
- A degree level or similar qualification in mechanical or industrial engineering.
- Minimum 1 years experience in a quality role within a regulated industry.
- Proven ability to successfully introduce new product development in the Medical Device Industry.
- Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
- Proven experience and training in Mechanical Engineering processes.
For further information on this Process Engineer role in Cork please contact Deirdre on 091730022 / firstname.lastname@example.org
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