Senior Quality Engineer
Galway
Permanent
Senior Quality Engineer
Role Overview
Key Skills & Experience
Nice to Have
Role Overview
- Provide support for Corrective and Preventive Actions (CAPA).
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Supports business initiatives for process improvement.
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
- May provide guidance, coaching and training to other employees within job area, and may manage projects requiring delegation of work and review of others’ work product.
- Interface with other departments to ensure that Quality system requirements are adhered to.
- Perform audits and provide audit support
- Approval of protocols, reports, and testing results
- All other duties as assigned.
Key Skills & Experience
- Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
- 5-8 years’ experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
- Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
- Knowledge of FDA and ISO compliance
- Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
- Ability to work well as part of team and also to lead a team
- High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.
- Ability to take initiative, to organize and prioritize own work and proactively contribute to project level strategies and planning.
- Effective time management skills.
- Ability to write engineering documents, test protocols, FMEAs
- Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.
- Able to analyze and chart data using MS Excel or Minitab
- Previous Quality Auditor experience is desirable, or certification is an advantage
Nice to Have
- Knowledge of quality tools:
- Risk analysis
- Root cause analysis
- Problem solving approaches
- May have practical knowledge of project management.
- Green Belt or Black Belt in DRM
- Experience in Pre or Post-Market Medical Device Design and Development
- Proficient use of statistical analysis software
- Experience with matrix structures, having already worked with cross functional teams within an international environment