Senior Quality Project Engineer
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With our 70-plus-year heritage, we are the largest eye-care device company in the world – with complementary businesses in Surgical and Vision Care. Being a truly global company, we work in over 70 countries and serve patients in more than 140 countries.
We are currently recruiting for a Senior Quality Project Engineer to join our team here in Cork. You research process technologies and process control improvements for site implementation. They apply comprehensive and diverse knowledge of engineering principles and practices for Quality focused process controls improvements. They use specialist knowledge and leadership in leading the execution of these improvement activities. A typical day in this role will include;
- Utilize Quality Engineering principles and problem-solving skills to improve and maintain processes that are aligned with the overall Quality and Business vision while ensuring production build schedule attainment.
- Responsible for introducing and validating new process control projects from design through completion and in compliance with regulatory requirements.
- Work with automation solution providers to specify, design and implement solutions if necessary. Responsible for supporting and improving existing process controls through process analysis and the application of engineering principles.
- Employ appropriate risk management to prevent unanticipated failure modes.
- Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as risk management documentation in accordance with regulatory requirements and internal Alcon requirements.
- Responsible for project management & planning and for liaising with other departments/plants affected by these projects. Also for reporting project status to management and highlighting areas of concern early. Responsible for ensuring all projects are completed to agreed timelines and within budget. Also that all work adheres to H&S and environmental requirements.
- Author/Reviews Test Methods, 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.
What You Will Bring To Alcon:
- Third level qualification in a Business or Engineering Discipline
- As minimum 5-10 years in a medical device or pharmaceutical environment
- Preferred 5 years’ experience in Medical Device or Pharmaceutical industry with a Bachelors degree in a technical discipline
- Knowledge of FDA, medical device, GMP and validation requirements.
- Experience in Equipment and process validations.
- Excellent Project management problem solving & analytical ability.
- Attention to detail with excellent organizational skills.
- Knowledge of Line Clearance and Product Segregation requirements Report writing expertise and highly developed people skills.
How You Can Thrive At Alcon
- A competitive salary package with fixed salary, bonus, pension and health insurance
- A flexible work environment with competent and committed colleagues. We enjoy working together in a good and respectful manner, and we celebrate our common successes
- See your career like never before with focused growth and development opportunities
Alcon Careers
See your impact at www.alcon.com/careers
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