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Quality Systems Engineer II - Permanent (Galway) Job

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Date: Nov 12, 2020

Location: Galway, G, IE

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.


We are currently looking for a Quality Systems Engineer II - (Permanent) to join our team in Galway



This is a very exciting time to join a growing and evolving Internal Audit team with a large scope to reshape the team and how they operate in a changing environment.  The role is diverse with a hands-on element of conducting audits along with a strategic role of shaping the function and partnering with the business. 


Job Purpose:  Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, 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.


Key Responsibilities

  • Demonstrate a primary commitment to patient safety and product quality.
  • Ensures  all  direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
  • Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs in Boston Scientific Ireland Ltd.
  • Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
  • Familiar with the internal auditing system.
  • Understands and proactively follows through on the Environmental Management Procedures that have been identified as relevant to position.
  • Acts as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.


Qualifications/ Experience

  • NFQ level 8 (240 credits) in Science, Quality or any other STEM discipline
  • Minimum requirement 3-5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
  • Strong understanding and experience in the implementation of ISO 13485, ISO 14971, MDR
  • Dynamic team player who will lead intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
  • May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
  • Leads intra or interdepartmental teams of an operational nature such as preparing the company for minor changes in regulations, continuous improvement initiatives.
  • Accredited lead auditor against recognised quality standards in support of internal audits
  • Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
  • Strong influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals along with coach / mentor the organisation audit function
  • Effective compliance reporting to senior management and relevant quality governance forums
  • Must have excellent written and verbal communication skills.

Job Segment: Quality Engineer, Engineer, Systems Engineer, Medical, CAPA, Engineering, Healthcare, Management