Cache of job #13918752

Job Title

QA Engineer

Employer

CPL

Location

Limerick

Description

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. __________________________________________________________________ MAIN DUTIES & RESPONSIBILITIES. 1. Actively work on compliance initiatives with the value stream and plant. 2. Work as integral member of project team and value stream process. 3. Compile Quality Process Specification for new/transferred products/processes. 4. Validate new/changed production processes/systems with Business Unit personnel. 5. Lead and participate in risk management activities. 6. Devise ad implement methods and procedures for inspection, testing and evaluation. 7. Prepare and execute validation for test method validations. 8. Ensure validation activities completed are compliant with regulations and quality system. 9. Assist in the development of sampling plans, test plans and data analysis related to process validation. 10. Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls. 11. Perform/document dimensional/visual inspections and non conformances and deviations as required. 12. Manage a variable workload to meet operational requirements. 13. Participate in cross-functional teams as required. 14. Ensure that all health, safety and environmental requirements are fulfilled. KEY COMPETENCIES REQUIRED: Excellent Communication Skills. Pro-active approach to work. Team Player. Flexible. Highly computer literate. High attention to detail. High work standards. Planner & organizer. Active listener. EXPERIENCE ESSENTIAL: Hons. Degree Quality/ Manufacturing / Engineering / Science. Minimum of 2+yrs experience in Quality Assurance/Engineering. Working knowledge of Quality systems (FDA/ISO) within a regulated environment. Test method validation experience is essential; Ability to analyze Capability data using MINITAB. Ability to interpret Engineering drawings/specifications. Familiarity in areas of various inspection techniques. Excellent interpersonal & communication skills. Other Skills, Experience and Education 5 yrs experience in a regulated environment. SIX SIGMA Certification Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA) Experience of the design and qualification documentation standards to current FDA expectations Knowledge of statistical packages and Microsoft Office systems required. Proven ability to review and critique Quality Critical technical documents. A good understanding and working knowledge of FDA and ISO regulations. Desirable Knowledge of lean manufacturing Five years experience as Quality Engineer working in a cGMP environment preferably in medical device. Positive attitude Continuous Improvement orientation Accepting of change Flexible - Calmly reacts to the unexpected. Credible Accountable for decisions Self-Motivated requires minimal direct supervision. Results focused maximizes business benefit from all activities. Innovation thinks laterally but within a compliant framework. Organized Able to cope with extensive documentation and planning requirements. Six Sigma or quality engineer certified, Structured problem solving and decision making skills working in a team environment. Ability to participate in or leading cross functional project teams Must have good written and presentation skills and be able to communicate effectively throughout organization Demonstrated Experience working with data base applications desired Ability to set priorities while ensuring compliance is not compromised. This job originally appeared on RecruitIreland.com.

Date Added

2082 days ago

Apply