Connecting...

Quality Engineer - Start Up

Job description

Quality Engineer

Based near Galway city, the Quality Engineer will report directly to the Quality Manager and work in a team of 5.

 

Key Responsibilities

  • Experienced in process validation techniques including risk management, statistical techniques in compliance with regulatory requirements.
  • Lead process risk management process in compliance with EN ISO 14971 and preparation of risk management files and FMEAs.
  • Responsible for the compilation and execution of Process Validation Protocols in conjunction with manufacturing.
  • Supports Supplier Qualification, Assessment and Audit process at key Suppliers.
  • Establish and maintain incoming, in-process & final inspections requirements and support design and validation test requirements as required.
  • Generates NCRs and CAPAs for product defects and non-conformities observed and follows up to ensure effective closure.
  • Manages sterilization activities, responsible for sterilization evaluation documentation and product release.
  • Supports the management of all calibration and maintenance programs for all equipment.
  • Manages validation and monitoring activities associated with particulate and biocontamination control.
  • Manages change requests in a timely manner and ensures effective closure.
  • Supports the training program and manages records for staff.
  • Drives changes in procedures and standards to facilitate Drives the metrics system / trending for all quality system measurable.
  • Interfaces with all departments (including Production, Design & Regulatory) on product development, transfer and improvement projects as required.
  • Supports the design verification process including reviewing protocols, reports, design and quality documentation supporting product development.
  • Support various Quality Management System activities including internal audits.

 

Skills, Qualifications & Experience

  • Degree in Biomedical engineering/science discipline or Quality Management together with experience in an engineering function, preferably within a medical device or related industry.
  • Minimum 2 years’ experience as Quality Engineer or similar role in a medical device manufacturing environment.
  • Must be a solutions provider.
  • Strong technical skills and analytical problem-solving ability combined with attention to detail to achieve project deliverables.
  • Knowledge of Medical Device Quality Management System Requirements ISO 13485, MDD 93/42 EEC, 21 CFR Part 820, CMDR.
  • Excellent interpersonal and communication skills.
  • Proven ability to work well as part of a team and on own initiative in a face paced environment.
  • Advanced PC skills such as Excel, Word, PowerPoint.

Desirable:

  • Experience or training in one or more of the following; Biocompatibility, Ethylene Oxide sterilization validation or microbiology.
  • Previous neurovascular medical device Design or Quality Assurance experience.
  • Prior experience in computer systems validation or Gamp 5.

 

For more information, please contact Emma on 091 455 307.

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.