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August 19 2018

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Offer: QA Engineer:

Job description:

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QA Engineer

function Description


The QA Engineer, plays a key function 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 connected with equipment and processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
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MAIN tasks & 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 expertise
Pro-active approach to work
Team Player
Flexible
Highly computer literate
High attention to detail
High work standards
Planner & organizer
Active listener 

practice ESSENTIAL:
Hons. Degree Quality/ Manufacturing / Engineering / Science
Minimum of 2+yrs practice in Quality Assurance/Engineering
Working knowledge of Quality systems (FDA/ISO) within a regulated environment
Test method validation practice is essential;
capability to analyze Capcapability data using MINITAB
capability to interpret Engineering drawings/specifications
Familiarity in areas of various inspection techniques
Excellent interpersonal & communication expertise 

Other expertise, practice and Education 5 yrs practice in a regulated environment. SIX SIGMA Certification practice in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA) practice of the design and qualification documentation standards to current FDA expectations Knowledge of statistical packages and Microsoft Office systems required.
Proven capability to review and critique Quality Critical technical documents. A good knowledge and working knowledge of FDA and ISO regulations. Desirable Knowledge of lean manufacturing Five years practice 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 broad documentation and planning requirements. Six Sigma or quality engineer certified, Structured problem solving and decision making expertise working in a team environment.

capability to participate in or leading cross functional project teams Must have good written and presentation expertise and be able to communicate effectively all over organization Demonstrated practice working with data base applications desired capability to set priorities while ensuring compliance is not compromised.

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Limerick City
Company Type Employer
Post Date: 07/16/2018 / Viewed 7 times
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