Job Description

  • Employment Type: Full Time
  • Job Location: Republic of Ireland, Cork
  • Date Posted: Posted 1 week ago
  • Date ClosesCloses 31/03/2022

JOB PURPOSE:

Reporting to the QE Leader Leader the Quality 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 DePuy R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

ORGANISATIONAL INTERFACES:

• All DePuy World Wide facility Quality, Operational and R&D. • DePuy Vendor management personnel.

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. Formatted: Font: 18 pt, Underline
  • 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.

TO ADHERE TO THE COMPANY’S PROCEDURES AS DETAILED IN THE CSOP MANUAL

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.
  • 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.

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