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QA Engineer - Contract

Job Title: QA Engineer - Contract
Contract Type: Contract
Location: Cork
REF: 96306
Job Published: 5 months ago

Job Description

Applicants must have a valid working visa for Ireland for this contract role

Contact: Niamh Hlubek
Telephone: 086 8168298

QA Engineer - Contract
Our client, a medical device company in Cork are currently looking to recruit a QA Engineer for their site on a contract basis

Job Purpose:
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
  • Actively work on compliance initiatives with the value stream and plant
  • Work as integral member of project team and value stream process
  • Compile Quality Process Specification for new/transferred products/processes
  • Validate new/changed production processes/systems with Business Unit personnel
  • Lead and participate in risk management activities
  • Devise ad implement methods and procedures for inspection, testing and evaluation
  • Prepare and execute validation for test method validations
  • Ensure validation activities completed are compliant with regulations and quality system
  • Assist in the development of sampling plans, test plans and data analysis related to process validation.
  • Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
  • Perform/document dimensional/visual inspections and non-conformances and deviations as required
  • Manage a variable workload to meet operational requirements
  • Participate in cross-functional teams as required.
  • 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

Qualifications & Experience
  • 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 analyse Capability data using MINITAB
  • Ability to interpret Engineering drawings/specifications
  • Familiarity in areas of various inspection techniques
  • Excellent interpersonal & communication skills
  • Process Validation experience
  • Six Sigma Certification (Green Belt / Black Belt)
  • High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations

For further information on this QA Engineer role in Cork please contact Niamh Hlubek 086 8168298 /

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