Overview
Senior Quality Assurance Engineer Jobs in Galway, County Galway, Ireland at Sigmar Recruitment
Title: Senior Quality Assurance Engineer
Company: Sigmar Recruitment
Location: Galway, County Galway, Ireland
About Your New Employer
Join a global leader in medical technology, services, and solutions, dedicated to improving patient outcomes through innovative solutions. You will work on cutting-edge medical devices that comply with international standards, ensuring global reach and influence.
About Your New Job
As the Senior Quality Assurance Engineer you will:
Ensure products are maintained throughout their lifecycle and comply with global standards.
Assess patient risk for design changes and provide QA technical direction for qualification and validation activities.
Generate protocols and compile data for regulatory submissions to support design change approval.
Work with Regulatory Affairs to present information clearly and minimize agency questions.
Establish strong relationships across the organization and with partners in a complex technical environment.
Maintain up-to-date knowledge of regulatory compliance for product design, development, and commercialization.
Collaborate with engineering and manufacturing to ensure quality standards, conduct tests, and perform statistical analysis.
May focus on design, material, production control, product evaluation, reliability, inventory control, or R&D as they apply to quality.
Understand and apply risk management concepts to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
What Skills You Need
Regulatory Knowledge: Expertise in FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
Technical Direction: Ability to provide QA technical input for qualification and validation activities.
Design Verification: Experience in generating protocols and compiling data for regulatory submissions.
Cross-Functional Collaboration: Strong ability to work across various functions and establish effective relationships.
Quality Assurance: Proficiency in conducting quality assurance tests and performing statistical analysis.
What’s on Offer
Attractive compensation package.
Opportunities for continuous learning and growth.
Work on products that make a difference worldwide.
What’s Next
Apply now by clicking the “Apply Now” button
