Senior Quality & Reliability Engineer

Job Description

The Snr Quality System Engineer is a member of the Quality Systems department. S/he is responsible for supporting and leading the organization in its’ drive towards optimum quality compliance to site as well as corporate policies and external regulations, while adhering to efficient and lean principles. The role will be responsible for working with the wider organization to ensure the effective and compliant implementation of the site Quality Management System and will prepare the site to demonstrate this compliance during regulatory audits. The role will also work across-site to lead and implement a number of projects that will transform the operating practices and systems of this Quality Management System.

Duties & Responsibilities

•    Actively stays current with external and internal quality system standards and requirements. 
•    Providing Quality Systems support for the Galway site.
•    Responsible for preparing the site to host external Regulatory audits (e.g., MDSAP) and demonstrating compliance as well as subsequent activities such as Lessons Learned Programs
•    Directly responsible for coordinating, managing, providing leadership and guidance for different areas (such Document Control and Training)
•    Responsible for coordinating Management Review and subsequent activities (Meeting Minutes, tracking actions)
•    Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards. 
•    Ensure compliance and drive improvements in QS processes.
•    Participates in Quality Systems projects under the direction of the Quality Systems Manager as well as other duties as assigned.
•    Developing and implementing processes, procedures, and instruction to sustain and improve the Quality Management System.
•    Supporting Quality Systems Manager in the development and implementation of quality systems strategies and objectives.
•    Coaching and mentoring the organization in working within Quality Management System
•    Working within cross-site teams to implement best practices in methods and systems that drive Quality Excellence within the Quality Systems team on best practice
•    Leading and maintaining Cross-training efforts within QS organization 
•    This is not an exhaustive list of duties or functions and may not necessarily comprise all the "essential functions".
 

Key Requirements

•    Must be familiar with all aspects and elements of a quality system, ISO13485 FDA QSR & MDSAP.
•    Must have experience of hosting audits from external regulatory agencies and corporate functions.
•    Experience for leading cross-functional teams would be a benefit.
•    Demonstrates ownership for the integrity of work
•    Able to work independently and consider options for completing work
•    Strong written and verbal communication skills
•    Proven ability to influence.
•    Excellent attention to detail 
•    Highly organized with strong ability to prioritize tasks and work on own initiative.
•    Trained Auditor ideally lead auditor training and/or experience

What your background should look like:

•    Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification in Quality Assurance.
•    Experienced Snr Quality Systems Engineer with a minimum of 3 years’ experience at that level within the Medical Device or related industry.
 

Competencies