LSC Seeks a Quality Engineer for a multinational medical device company based in Cork.
The QA Engineer, plays a key role in the planning and execution of validation activities related to product transfers, new technologies, process changes and inspection methods. Lead test method validations and provides support for the validation activities associated with equipment and processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
The Quality Engineer will be responsible for:
o Actively work on compliance initiatives with the value stream and plant
o Work as integral member of project team and value stream process
o Compile Quality Process Specification for new/transferred products/processes
o Validate new/changed production processes/systems with Business Unit personnel
o Lead and participate in risk management activities
o Devise and implement methods and procedures for inspection, testing and evaluation
o Prepare and execute validation for test method validations
o Ensure validation activities completed are compliant with regulations and quality system
o Assist in the development of sampling plans, test plans and data analysis related to process validation.
o Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
o Perform/document dimensional/visual inspections and non conformances and deviations as required
Qualifications and Experience:
o Hons. Degree Quality/ Manufacturing / Engineering / Science
o Minimum of 2+yrs experience in Quality Assurance/Engineering
o Working knowledge of Quality systems (FDA/ISO) within a regulated environment
o Test method validation experience is essential;
o Ability to analyze Capability data using MINITAB
o Ability to interpret Engineering drawings/specifications
o Familiarity in areas of various inspection techniques
o Process Validation experience
o Six Sigma Certification (Green Belt / Black Belt)
o High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
Call Martin at LSC on 021 4777 329 for more information on this new position or apply directly via this advert.