- Reference: GJ43408
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
As NPI / Quality Systems Engineer you will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls for new and existing product and processes in the Galway facility.
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- Ensuring continued compliance with DMR
- Engineering Change Order (ECO)
- Failure Mode Effect Analysis (FMEA)
- Supervision, direction mentoring, performance review, developmental plans of quality technicians
- and documentation control personnel to ensure compliance for their areas of responsibility.
- Ensure the company behavioural standards are adhered to, setting the example yourself for your direct reports.
- Ensure that in your absence your department provides adequate day to day service. Ensure that other departments know of your arrangements well in advance.
- Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.
- Responsible for all quality aspects of new product & process introduction including:
- Responsible for the successful completion of all quality aspects of customer FARFs associated with NPI
- Management of the CAPA program and compile CAPA metrics & Quality Data Input
- Act as SME (subject matter expert) with respect to complaint handling.
- Experienced in management of Document Control.
- Act as SME with respect to Internal Auditing for the site
- Assist internal audit team with respect to planning/content of audits/ audit reporting / corrective action plans
- Management of the supporting elements of the Quality Management system.
- Takes a leadership role in developing and implementing new techniques and initiatives to enhance the QMS
- Participates in external regulatory audits
- Compile monthly Quality Reports.
- Perform Quality Systems Trending by compiling; monthly quality reports, raw data for Quality KPIs and trending for Operations Reviews and Management Reviews
- Conduct detailed root cause analysis on design related non-conformances, developing effective preventive measures to prevent recurrence.
- Playing a role in the plant annual objectives.
- Project meeting attendance as required.
- Work efficiently using own initiative, escalating decisions to the Quality and Regulatory Manager as, when, and only when, necessary.
Skills, Experience and Qualifications:
- Engineering or science Degree preferably with Quality Engineering included.
- The abilitity to work effectively with close tolerances in a fast paced demanding environment.
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead.
- Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance
- Good presentation skills to conduct training and presentations
- Knowledge of engineering theories and methods.
- Good technical report writing skills.
- Rigorous attention to detail.
For a confidential discussion and more information on the role/company please contact Christopher O’Toole on 091-706713 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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