Software Quality Engineer:
Our client, a medical devices manufacturer based in Galway, now seeks a Software Quality Engineer to ensure Software compliance on Production units.
The successful candidate will develop, establish, maintain and audit quality engineering methodologies, systems, and practices which meet both our clients and their customer’s regulatory requirements.
This is an initial contract role with a competitive salary and benefits, there is an excellent chance of been made permanent and I can disclose more details on application.
Responsibilities of Software Quality Engineer:
- 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 company 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, and resolving quality issues.
Requirements for Software Quality Engineer:
- HETAC level 8 degree in Science/Engineering/Software discipline preferably in Medical Devices.
- 3/4 years relevant experience within a software regulated environment.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision.
For more information and in strict confidence please send an up to date CV and cover note to John Reid at the RFT Group
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.