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Software Quality Assurance Engineer

Job Title: Software Quality Assurance Engineer
Contract Type: Contract
Location: Galway
Industry:
REF: 83071
Job Published: over 1 year ago

Job Description

Software Quality Assurance Engineer (12 month contract)

Our client, a medical device company in Galway are currently looking to recruit a Software Quality Assurance Engineer for their site.

Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Software Quality Engineer II.

Purpose
Develops, establishes, maintains and audits quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
This role will support DES Production Unit.

Responsibilities

  • Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
  • Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
  • Reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and where applicable Risk Assessments along with associated documentation for equipment and systems.
  • Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
  • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
  • Provides guidance to staff across various functions on software validation to ensure best practice is maintained. Provides guidance and assistance when required with the preparation of validation protocols, software design specifications and associated documentation for equipment and systems.
  • Provides software validation/compliance/part 11 guidance in accordance with policies and SOPs.
  • Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
  • Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
  • Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
  • Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
  • Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
  • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
  • Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment, systems and processes.
  • Provides software validation/compliance/part 11 training and collaboration in accordance with policies and SOPs.
  • Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.

Qualifications:
  • Min. HETAC level 8 degree in Engineering, IT, Quality or any other relevant discipline.
  • Strong Leadership & influencing skills
  • 5-8 years? relevant experience within a software regulated environment


For further information on this Software Quality Assurance Engineer role in Galway please contact Jessica Crowley on 086 0462367 / jessica@ccprecruit.ie
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