Our client is a global leader in the thriving Medical Device Industry. Committed to enhancing patient outcomes and healthcare provider safety, our client's operations span the entire product fulfillment process, from raw material procurement to the delivery of finished products. This role will present you with optimum opportunity to grow your career (step to lead engineer) as this is a part of a brand new team creating lots of opportunity as the team size plans to double over the next 12 months. The Senior Quality Engineer will also be given lots of Autonomy and Ownership to make change within the org, allowing you to put your own stamp on procedures from a quality perspective.
Responsibilities:
Provide expert Quality Engineering support for critical projects, including new supplier changes and qualifications.
Identify and assess risks within projects to ensure comprehensive quality management and regulatory compliance.
Lead quality initiatives and drive continuous improvement efforts within a regulated medical device manufacturing environment.
Collaborate closely with cross-functional teams, including Sustaining Engineering, Regulatory, and Supply Chain, to implement effective change management strategies.
Oversee supplier relationships, contributing to supplier selection, quality agreements, and process qualifications.
Develop and maintain comprehensive documentation, records, and quality management practices to ensure compliance.
Utilize project management tools to define project deliverables, establish schedules, and develop project charters.
Proactively manage project scope changes, identify potential issues, and develop contingency plans.
Facilitate effective stakeholder communication, ensuring project status and issues are well-communicated.
Work collaboratively with suppliers to devise robust process-validation strategies.
Requirements:
Bachelor's degree in Engineering or related field.
Minimum of 5 years of experience in R&D/QA/RA within the medical device industry.
Substantial experience in R&D, QA/RA, and validations.
In-depth knowledge of industry regulations, including ISO 13485, ISO 14971, and FDA 21CFR820.
Join our client's team to play a vital role in enhancing the quality, efficiency, and innovation of their medical device manufacturing operations.
For more information please contact Cathal Herron:
cathal.herron@collinsmcnicholas.ie
(090) 645 0660