Job description

About Your New Employer  

You will work as a Senior Software Quality Assurance Engineer for a company that helps save a life every 5 – 8 seconds across the world. Not only that, but they also offer excellent benefits and amazing, structured career development plans. You will join their mission on a permanent basis with your new job as a Senior Software Quality Assurance Engineer. There are positions available for this job both on their Galway and Cork site. 

About Your New Job    

As a Senior Software Quality Assurance Engineer you will... 

• Develop, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet Boston Scientific and external regulatory requirements.  
• Act as an effective team member providing independent review and guidance on deliverables used to develop, implement, and maintain IT/clinical/manufacturing/quality software. 
• Acts as a subject matter expert on software validation to guide/ coach/ train project teams on effective and efficient implementation of BSC software validation processes. 
• Demonstrate mastery of the software validation processes at BSC (examples include GSM, Spreadsheet Validation). 
• Work with the management to understand priorities and plans/provides input to resource and time allocation accordingly. 
• Play key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement a validation strategy to ensure compliance. 
• Guide implementation of enterprise systems solutions through planning, system integration, and verification and validation activities. 
• Proactive involvement in continuous improvement activities while ensuring that Boston Scientifics’ software systems are defensible for regulatory requirements. 
• Contribute to the development, review and / or approval of SOPs and supporting Work Instructions. 
• Demonstrate expertise to effectively communicate within all levels of the organization around concepts of Software verification and validation activities. 
• Communicate the value of the Software Quality process at Boston Scientific and champions departmental or cross-functional software validation initiatives.  Ensures buy-in from project team members to the disciplines, decisions and practices of the Software Validation. 
• Provide structured Quality Assurance activities and metrics to promote efficient and cost-effective operations. 
• Assure that appropriate resources(personnel, tools, tce.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. 
• Establish and promote a work environment that supports the Quality Policy and Quality System 

What Skills You Need  

For this job you will need: 

• Bachelor’s level degree (240 credits) in Science/Engineering/Software discipline. 
• 6 years of related experience, including 3+ years’ experience in Software Quality Assurance and validation. 
• People Leadership experience is a preference.  
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices 
• Must have good understanding of quality system requirements and how each quality system element connects. 
• Experience working with a diverse population of internal and external customers. 
• Experience managing projects and project deliverables to completion. 

What’s on Offer  

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get: 

• Annual Bonus 
• Fully covered Health Insurance for you and your family 
• Pension Scheme 

What’s Next 

• Apply now for this job by clicking the “Apply Now" button or call me, Lauryn Flanagan on 091 455 306  

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.