Senior Software Quality Engineer – Medical Devices | Limerick, IRE

Senior Software Quality Engineer

📍 Location: Limerick, Ireland
🏢 Work Model: Hybrid – Minimum 4 days onsite
💼 Employment Type: Full-Time
💰 Salary: €60,000 – €70,000
✈️ Travel: Occasional
🎓 Education: Bachelor’s Degree in Engineering or related technical field

Role Overview

A leading global medical technology organization is seeking a Senior Software Quality Engineer to support research and development programs focused on innovative medical technologies.

This role will be responsible for establishing and maintaining software quality processes, regulatory compliance, and design control systems to ensure the successful development and delivery of high-quality medical device software.

The position plays a key role in new product development, manufacturing transfer, and quality management system implementation, ensuring software systems meet both regulatory standards and customer expectations.

Key Responsibilities

Software Quality & Compliance

• Develop and maintain software quality strategies, processes, and procedures

• Ensure compliance with medical device regulatory standards including:

• FDA 21 CFR Part 820

• FDA 21 CFR Part 11

• ISO 13485

• ISO 14971

• IEC 62304

• EU MDR 2017/745

• Guide computer system validation (CSV) and electronic records compliance

Design & Development Quality

• Support software lifecycle activities including:

• Requirements management

• Software development planning

• Risk management

• Verification & validation (V&V)

• Facilitate design reviews and functional reviews

• Review and approve technical documentation including:

• Design documentation

• Verification and validation protocols

• Product drawings

Cross-Functional Collaboration

• Represent the Quality function within New Product Development teams

• Work closely with R&D, manufacturing, and engineering teams

• Support technology transfer initiatives between development and manufacturing environments

Continuous Improvement & Quality Systems

• Contribute to the development and implementation of quality management systems

• Support CAPA investigations and remediation activities

• Drive improvements in test coverage, software reliability, and system performance

Data Analysis & Problem Solving

• Apply statistical tools and quality methodologies to:

• Identify root causes

• Analyse product or process issues

• Implement corrective actions

Required Qualifications

• Bachelor’s degree in:

• Software Engineering

• Electrical Engineering

• Biomedical Engineering

• Mechanical Engineering

• Or a related technical discipline

• 6–7 years of professional experience in engineering or quality roles

• At least 4+ years of experience in software development lifecycle or software quality

• Strong understanding of medical device regulatory requirements

• Experience with:

• Software validation

• Design controls

• Risk management processes

• Strong analytical, problem-solving, and communication skills

Preferred Experience

• Experience in medical devices, healthcare technology, or regulated environments

• Familiarity with CAPA processes and audit remediation

• Knowledge of:

• Six Sigma methodologies

• Root cause analysis tools

• Statistical sampling techniques

• Experience working on cross-functional product development teams

Ideal Candidate

The ideal candidate is a software quality specialist within regulated industries who:

• Has strong experience in medical device software compliance

• Understands design controls and validation processes

• Can support new product development programs

• Works effectively with cross-functional engineering teams

• Applies structured problem-solving and quality methodologies

Why Join

• Opportunity to work on cutting-edge medical technologies

• Collaborative engineering and research environment

• Work with global teams driving healthcare innovation

• Strong culture of professional growth and technical excellence

Director of Laboratory - Paris, TX $95,000 - $120,000

Director of Laboratory  - Paris, TX
$95,000 - $120,000

We are looking for a Director of Laboratory services to be based on-site in Paris, Texas. You will be responsible for direction and coordination of the personnel in Clinical Laboratory services. Activities included will be performance of chemical, microscopic, blood bank and bacteriologic tests performed in the Clinical Laboratory to obtain data for use in diagnosis and treatment of diseases.

You will ensure that services are of the best quality, are cost contained and are carried out in an expeditious manner. You will also be responsible for recognizing results or problems that require referral to the Clinical Laboratory Pathologist and maintain performance improvement activities within the department and participates in CQI activities, formulates budget and maintains effective physician and intradepartmental relations. Plus, other duties as assigned.

Our client values people and strives to create an environment where individuals are recognized for who they are, not just what they can do

This is a full-time, on-site role based in Paris, TX. No visa sponsorships are included.

Must Haves:

• Bachelor of Science Degree in Medical Technology, Biology, Chemistry or Physical Sciences.

• MT (ASCP) required

• Minimum of three years managerial experience in the clinical laboratory of an acute care hospital (in non-waived testing).

• Prefer experience with regulatory and accreditation of laboratory operations.

Nice to Have:

• Master’s degree preferred

Package information:

Salary: $95,000 to $120,000 per year

+ Signing Bonus + Partial Relocation Package

Hours: Full-time.

Locations: Paris, TX

Job type: Permanent

Job reference: CRD-DLS

· Medical Insurance

· Vision Insurance

· Dental Insurance

· Life Insurance

· PTO