Job Description
Our client, a blue-chip multinational healthcare provider, now weeks a Software Quality Engineer to coordinate activities relating to the implementation and maintenance of the Quality System to ensure compliance with Corporate, EC, FDA and Canadian requirements.
The successful candidate will be Site Subject Matter Expert (SME) person and coordinator for computer validation / test activities.
This is a permanent role with Boston Scientific Cork facility quality team.
Responsibilities of Software QA Validation Engineer:
Leads the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all Computer Systems applications.
Leads project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
Determines Project schedules for remediation of legacy systems and works with cross functional teams to ensure adherence.
Site SME for computer software validation during internal and external audits.
Ensure regulatory compliance with internal and external validation regulations.
Drive continuous improvement initiatives within the Quality systems department.
Provide software validation/compliance/part 11 leadership.
Take part in vendor audits of critical equipment vendors.
Requirements for Software QA Validation Engineer:
Bachelor's Degree in Information Technology/Computer Science or equivalent is desirable.
3+ years' experience in a similar role, preferably in a large multinational company.
Demonstrate strong communication and problem solving skills. Customer focused approach.
Flexibility in working off- peak hours as support or project activities demand.
Proven IS background in some of the following: Net, VB, SQL, Web Development, Relational databases.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group: Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie / www.meddevicejobs.ie
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Key words; Quality Systems, Validation Engineer, Equipment Validation, Software Systems Validation, CSV, Computer Systems Validation, New Product Introduction, Pharmaceutical, Medical Devices, Limerick, Cork, Tipperary, Waterford, Munster.