Boston Scientific Quality Systems Engineer I/II 

Ireland, Galway 

108161258

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Job purpose:

You will demonstrate commitment to the Quality Policy through your daily execution of sound quality practices and the maintenance of an effective quality system and complying with regulations governing the quality system. This position will involve supporting Quality System activities related to Quality System Management with a focus onGalway Site Quality Reviews (QMR, MQU & Feeder), Quality Planning and/or Internal/External Audit and may include, NCEP/CAPA.

Key Responsibilities:

• Assist in developing effective metrics.
• Compile metrics and report results as required to key stakeholders.
• Support training as required for Quality System Processes.
• Co-ordinate and assist in the preparation and maintenance of the records associated with QMR and other Galway site quality reviews.
• Supporting the coordination and completion of Internal and External Audits as applicable
• Be knowledgeable on QSR and ISO/MDR standards, constantly promoting awareness of best industry practices, making appropriate decisions on a daily basis.

• Be knowledgeable on Risk Management EN 14971 requirements.
• Deal with competent authorities, notified bodies as well as other engineering disciplines within and outside of the Site and customers should the need arise.
• Support Quality System enhancement projects and continuous improvement initiatives including:
  • Utilization of project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables, and meet timelines
  • Driving continuous improvement and globalization by gaining alignment across stakeholders/functions while meeting BSC and regulation requirements
  • Resolving project roadblocks and obstacles by working with team members, project customers, others, and escalating to management as appropriate
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and quality issues and driving continuous improvement

Education & Experience:

• Level 8 degree (240 credits) or equivalent in and Engineering or Science related discipline.
• A minimum of 1-5 years’ experience, depending on level, working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
• Familiar with the Internal Audit process.
• Familiar with CAPA / NCEP Processes.
• We would like you to be a team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
• Excellent verbal and written communication, interpersonal, organizational, and presentation skills; must be able to multi-task and work well under deadlines.
• Attention to detail and ability to analyse information quickly. Data Analysis experience is an advantage.
• Ability to collaborate and communicate with all levels of the organization.
• Use a risk-based approach for making quality and business decisions.
• Hands-on Project Management experience.
• Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR 2017/745 with ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements.
• Continuous improvement mindset with a passion for Quality.

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