Explore senior quality engineer jobs in Galway, where opportunities abound for experienced professionals. These roles demand expertise in quality assurance, testing methodologies, and process improvement. Senior quality engineers are vital in maintaining high standards and driving continuous improvement within organizations. Galway’s job market offers a range of senior quality engineer positions across diverse industries, including manufacturing, technology, and pharmaceuticals. These roles often involve leading quality control teams, developing quality management systems, and ensuring compliance with regulatory requirements. Candidates should possess strong analytical skills, attention to detail, and a solid understanding of quality standards. Job seekers can find senior quality engineer roles that match their skills and experience, contributing to the success of Galway‑based companies. The demand for skilled quality professionals remains strong, making Galway an attractive location for career advancement in quality engineering.
Senior Quality Engineer – Zimmer Biomet
Posted 14 days ago
Responsible for developing, implementing, and maintaining risk management systems and processes to ensure compliance with regulatory and quality standards, as well as leading site investigations into any issues.
Conduct risk assessments, identify potential risks in products and processes, and collaborate with cross‑functional teams to implement corrective and preventive actions.
Ensure products conform to established requirements and standards through appropriate audit, inspection, and test activities.
Interact with various functional departments, suppliers, and external experts to implement Zimmer Biomet quality goals.
Develop and implement processes, procedures, and instructions to sustain and improve the Quality Management System.
Perform risk assessments on processes and equipment to identify potential hazards.
Support top management in developing and implementing quality systems strategies and objectives.
Identify and solve product and process problems.
Support operational and manufacturing groups and suppliers in resolving and preventing quality issues.
Perform quality engineering analysis and responses for corrective/preventive actions.
Assist and verify the implementation and effectiveness of corrective/preventive actions taken for non‑conformance.
Conduct audits and assessments of internal processes and supplier manufacturing sites.
Develop validation strategies and support successful execution of the same.
Represent the site during external regulatory audits.
Must be familiar with all aspects and elements of a quality system including management responsibility, resource management, product realization and measurement, analysis and improvement processes.
Knowledge of quality assurance techniques such as inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control.
Demonstrated technical expertise and ownership for the integrity of work.
Ability to work independently or as part of a team and consider options for completing work.
Strong written and verbal communication skills.
Bachelor’s Degree in Quality or Engineering field, or an equivalent combination of education and experience.
Familiarity with Microsoft Office Suite.
Minimum 5 years of experience in Quality Engineering field.
Experience working in a regulated industry, preferably medical devices.
Salary Range: €60,000 to €85,000 per year.
EEO Statement: EOE/M/F/Vet/Disability
Senior Design Quality Engineer – Medtronic
Posted today
Develop, modify, apply, and maintain quality standards and protocols for processing materials.
Collaborate with engineering and manufacturing teams to establish and uphold quality standards, ensuring alignment with regulatory requirements.
Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Specify inspection and testing mechanisms and equipment; conduct quality assurance tests; perform statistical analyses.
Ensure corrective measures meet acceptable reliability standards and documentation complies with regulatory requirements.
Specialize in areas such as design quality, incoming material inspection, production control, product evaluation and reliability, inventory control, and R&D as applicable.
Review and approve quality documents from a regulatory standpoint to ensure compliance with industry standards.
Drive continuous improvement initiatives across processes, fostering a culture of quality and accountability.
Provide training and support to team members on quality standards and best practices.
Bachelor’s degree in engineering with a minimum of 4 years of relevant experience, or Master’s degree with a minimum of 2 years, or PhD with 0 years of relevant experience.
Mechanical, Electrical engineering, or a related field.
Minimum 4 years of industry experience.
Experience in medical device quality assurance with a strong understanding of regulatory requirements.
Excellent analytical skills and ability to work independently on moderately complex projects under limited supervision.
Preferred specialization in design quality and support for R&D and production activities within the interventional therapy space.
Strong communication and interpersonal skills.
Salary Range: 62,320.00 EUR – 93,480.00 EUR.
EEO Statement: EOE/M/F/Vet/Disability
Senior Design Quality Engineer – RPE – Mervue – Medtronic
Posted 5 days ago
Critically review new and modified product designs to determine impact on existing or new product requirements.
Ensure design changes comply with Medtronic’s QMS, ISO 13485, EU‑MDR, and FDA Quality System Regulations.
Lead cross‑functional teams to develop product risk management files.
Assist in the creation of verification and validation test plans, protocols, and reports; review testing and analysis for standards compliance.
Perform root cause analysis and corrective/preventive actions.
Provide training and support on quality standards.
4+ years of quality experience with a Bachelor’s Degree, 2+ years with a Master’s Degree.
Experience in medical device industry.
Experience in ISO 13485, ISO 14971, IEC 60601, and EU‑MDR regulations.
Proficiency with CAPA, risk management, and validation test planning.
Knowledge of statistical analysis tools (e.g., Minitab).
Strong communication skills.
Preferred: experience with electronic design, PCB, or lean methodologies.
Salary Range: 62,320.00 EUR – 93,480.00 EUR (plus MIP).
EEO Statement: EOE/M/F/Vet/Disability
Senior Quality Systems Engineer – Zimmer Biomet
Posted 16 days ago
Ensure compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
Lead and support QMS processes, including CAPA, Issue Evaluations, Quality Management Reviews, internal and external audits, and change management activities.
Collaborate across functional departments and interact with external experts.
Develop, implement, and continuously improve QMS processes, procedures, and instructions.
Act as SME for CAPA and Issue Evaluations.
Lead internal audit program and support external audits.
Host and manage regulatory inspections, including Notified Bodies and FDA visits.
Support change management activities, preferably using Windchill or similar PLM systems.
Drive process simplification and implement innovative, technology‑driven solutions, including AI‑based tools.
Prepare and lead Quality Management Reviews.
Collaborate with operational and manufacturing groups and suppliers to resolve and prevent quality issues.
Provide training and coaching on QMS requirements.
Bachelor’s degree in engineering or scientific discipline (or equivalent with CQE certification).
Minimum 5+ years of experience in Quality Systems, Quality Engineering, or Quality Compliance within a regulated industry (medical device preferred).
Experience with Windchill or similar PLM systems highly desirable.
Proven experience hosting regulatory inspections (NBs, FDA).
Familiarity with Microsoft Office Suite.
EEO Statement: EOE/M/F/Vet/Disability
Supplier Quality Engineering Manager – Medtronic
Posted 16 days ago
Guide, grow, and motivate a talented and diverse team responsible for developing and implementing supplier quality strategies, policies, and procedures.
Set clear goals, expectations, and development plans for direct reports.
Monitor and report supplier quality metrics and use information to build strong relationships with supplier partners.
Provide regular coaching, feedback, and complete performance reviews.
Identify training opportunities and support professional growth.
Collaborate with cross‑functional and cross‑site teams to establish supplier quality requirements.
Manage functional resource allocation.
Ensure compliance with company policies and external standards.
Generate solutions to process, engineering, and organizational challenges.
Level 8 Degree or higher in Engineering, Science, IT, or related discipline.
5 years of direct managerial experience of engineers.
Excellent team building, communication, people management skills.
Experience in the medical device market with a proven results‑driven record.
Salary Range: 83,760.00 EUR – 125,640.00 EUR.
EEO Statement: EOE/M/F/Vet/Disability
Quality Engineering Program Manager – SH&A – Medtronic
Posted 3 days ago
Lead product escalations across cross‑functional groups.
Monitor product performance, complaint investigations, and evaluate quality issues impacting released product.
Support Design Assurance activities supporting changes to commercial products.
Mentor team members through technical problem solving including CAPA investigations.
Provide technical knowledge and input into risk assessments.
Provide front‑room support during inspections from regulatory agencies.
Communicate and negotiate with internal cross‑functional employees, internal leaders, and external customers.
Create strategic plans for driving efficiencies, improving competencies, and developing people.
Provide oversight and expertise in risk management activities.
Effectively communicate and provide updates on high visibility patient‑impacting issues to senior leadership.
Bachelor’s degree and a minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices.
5 years of experience working in the regulated medical device industry.
Root cause analysis and leading technical investigations with cross‑functional groups.
Lead projects to solve technical problems or process improvement programs.
Experience working on post‑market quality/complaint handling teams.
Salary Range: 83,760.00 EUR – 125,640.00 EUR.
EEO Statement: EOE/M/F/Vet/Disability
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