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