Software Engineering , IT
Software QA Engineer
- Galway, County Galway, Ireland
PE Global is recruiting for a Software Quality Assurance Engineer for our medical device client in Galway. This is an initial 12-month contract, hybrid role.
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.
· 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.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
· Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
· Establishes and promotes a work environment that supports the Quality Policy and Quality System.
A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.
Plans, organizes, and prioritizes own daily work routine to meet established schedule.
Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpreting established policies, procedures and practices. Work is reviewed for soundness of judgment.
Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.
Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.
Provides training and collaboration to less experienced staff.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***