Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Karl Lippett
email it@hero.ie

Software Quality Engineer

Software Quality Engineer (CSV)

Lead Quality, Compliance and Computer Software Validation (CSV) activities in relation to software used in business systems, laboratory & manufacturing equipment, product development and products.

Responsibilities:

  • Continue to meet the requirements of relevant regulations and are fit for purpose.
  • Collaborate with project teams to determine the validation strategy and plan for execution.
  • Quality reviewer on CSV and system supporting documentation.
  • Lead Quality and Compliance activities in relation to Software projects.
  • Author computer system validation documentation; test scripts, protocols, reports.
  • Pre and post execution approval for all validation test scripts.

Qualifications:

  • Computer Software Validation within the medical device industry
  • Experience of implementation and validation software business systems is desired.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR
  • Familiarity with GAMP5 Guideline for 'Risk Based approach to GxP Compliant Computerised systems.

For further information on this role please contact Karl Lippett on 0861070950 / it@hero.ie
 
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
 
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

107241

  Apply with Linkedin   Apply with Indeed
Software Quality Engineer

Karl Lippett

Role Type Permanent
Contact Karl Lippett
email it@hero.ie
mobile +353 86 107 09 50
linkedIn profile click here

Production Supervisor

Galway

Production Supervisor We are currently looking for a Production Supervisor to join our Polymer Core Technology department in an Evening…

 

Read More

Junior Maintenance Engineer

Netherlands

Maintenance Engineer – Junior 24 month contract As an all-round Maintenance Engineer you are responsible for: Maintaining, revising and modifying:…

 

Read More

Quality Engineer

Galway

Quality Engineer A leading Medical Device company in Galway is looking to hire a Quality Engineer for their site on…

 

Read More