The Opportunity in Cork:
My client's facility in Cork manufactures a life-changing medical devices that truly change their patients' lives for more than 25 years. The team in Cork has grown from 13 associates to more than 450. Patients are at the centre of everything that my client does and are at the heart of their commitment to quality. You will receive a competitive salary and benefits for this permanent position.
The Role of Senior Quality Engineer:
As Senior Quality Engineer, you would be reporting to the Quality Engineering Manager; planning, conducting and providing direction on all quality engineering activities. You will apply comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas.
Day-to-Day Accountabilities of Senior Quality Engineer:
- Direct supervision of Quality Engineers including all recruitment, performance reviews and career development.
- Utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision while ensuring production build schedule attainment.
- Lead and manage investigations providing formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes.
- Employ appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
- Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as master validation plans and risk management documentation in accordance with regulatory requirements and internal Alcon requirements.
- Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
- Reviews Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned.
- Perform an active role in further development of the quality management system and drive continuous improvement and innovation from a quality perspective.
- Actively participate in external audits by Notified Bodies and Health Authorities as subject matter expert for areas of responsibility and guide audit preparation activities within the Quality Engineering group.
Skills & Requirements of Senior Quality Engineer:
- Knowledge of FDA, medical device, GMP and validation requirements.
- Experience in Equipment and process validations.
- Knowledge of Statistics
- Skills: Project management, problem solving, statistical analysis and word processing.
- People management experience.
- Bachelors degree in a scientific/engineering discipline (level 8)
- 6+ years technical quality experience in the medical device industry, including as a quality/validation engineer at an advanced level.
- EU Passport/Stamp 4 Visa for consideration.
Interested? Want to hear more? Apply today if you meet the requirements and I will follow up with you!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales