We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Main duties and responsibilities:
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises, implements and monitors methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Participate in preparing / critically reviewing/approving NCMRs/ CAPAs/ Investigations and validation activities, providing expert QA technical direction and solutions as appropriate.
• Ensures effective product control measures in the event of issues being noted.
• Lead and support root cause driven approaches to problem solving efforts for quality issues and implements corrective & preventative actions.
• Ensures that root cause of problem & implements corrective & preventative action measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Liases with other departments sites, functions and vendors on a frequent basis. Represents the site at various levels in the organisation. Makes decisions in conjunction with senior management on deadlines that impact the business unit.
Education & Experience
•We are looking for a qualified person to Bachelor’s Degree (Level 8) in Science/Engineering or related Discipline. Requires a minimum of 3-5 years of relevant experience. A minimum of a Masters or PhD degree in Cell/Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
• Established and productive individual contributor.
• Works independently with general supervision on larger, moderately complex projects / assignments.
• Communicates frequently with internal & external contacts.
• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Practical analytical laboratory experience in a GLP/GMP environment is advantageous.