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Process Engineer

Job Title: Process Engineer
Contract Type: Contract
Location: Cork
Industry:
REF: 87226
Job Published: 7 months ago

Job Description

Contact: Deirdre Finnerty
Email: deirdre@hero.ie
Telephone: 091730022

Process Engineer
Our client, a medical device company in Cork are looking to recruit a Senior Mechanical Engineer for their site on a contract basis

Job Purpose
  • 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
  • Flexible
  • Team player
  • Good influencing skills
  • Project Management skills
  • Good generalist (experienced quality person)
  • Methodical
  • 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 / deirdre@hero.ie
Check out all our open jobs on our website - www.hero.ie