Quality Assurance Engineer

Maclivaro Limited; Dublin; Hybrid; EUR 55,000 - 65,000; Full time

Job summary

An established industry player in the medical device sector is seeking a skilled Design Assurance Engineer to join their dynamic team in Dublin. This exciting role offers the opportunity to oversee the design and development process, ensuring compliance with the highest quality standards. You will lead documentation efforts, conduct risk assessments, and collaborate across teams to deliver exceptional results. With a focus on career growth, this position allows you to shape your future within a small, innovative company. If you're passionate about quality assurance and eager to make an impact, this opportunity is perfect for you.

Qualifications

• Experience in design assurance and risk assessment in medical device industry.
• Strong understanding of regulatory compliance and documentation processes.

Responsibilities

• Lead documentation and risk assessments throughout the design process.
• Manage customer-facing activities and ensure compliance with standards.
• Oversee multiple projects ensuring quality and timely delivery.

Skills

Design Assurance

Risk Assessment

Documentation Management

Regulatory Compliance

Project Management

Education

Bachelor's degree in Engineering or related field

Tools

Technical File Management

Quality Assurance Tools

Job description

This range is provided by Maclivaro Limited. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Design Assurance Engineer – Farnham, England (Hybrid) – €55,000 - €65,000

Are you an experienced Design Assurance Engineer looking for an exciting new opportunity? We’re working with a leading wound care medical device business that specializes in high-quality manufacturing and innovation. They are currently seeking a skilled Design Assurance Engineer to join their growing team in Dublin, where you’ll be involved in the full end-to-end process from design concept to contract manufacturing.

About the Role: As a Design Assurance Engineer, you will play a vital role in the Design Assurance Department, overseeing every stage of the design and development process. Working closely with the QARA Director, you will be responsible for ensuring that products meet the highest quality standards and regulatory requirements. You’ll be involved in numerous projects simultaneously, helping to drive them forward and ensuring the team delivers on time and to the highest standards.

Key responsibilities include:

• Leading Documentation & Risk Assessments: Overseeing the documentation process and performing thorough risk assessments at every stage of the development cycle.
• Reviewing & Developing Protocols: Reviewing and developing design protocols, validation plans, and technical files, ensuring compliance with regulatory standards.
• Risk Mitigation: Identifying, assessing, and mitigating risks across the design and manufacturing process to maintain product safety and compliance.
• Managing Customer-Facing Activities: Handling labelling, timelines, and customer communications, ensuring that all external interactions are managed professionally and in line with the company’s high standards.
• Preparing Summary Reports: Creating detailed summary reports to track progress and ensuring all design assurance activities align with internal and regulatory standards.
• Trace Stability: Ensuring product traceability throughout the development process to maintain complete compliance with relevant regulations.
• Compiling Technical Files: Managing and compiling comprehensive technical files, ensuring all necessary documents are prepared and available for audits and regulatory submissions.
• Collaboration Across Teams: Working closely with the test and quality departments to ensure smooth project delivery and to address any quality concerns in real-time.
• Project Management: Overseeing multiple projects simultaneously, ensuring each one meets deadlines and quality expectations while managing risk and compliance effectively.

Long-Term Career Growth: This is a unique opportunity within a small, growing team, which means you’ll have the real chance to branch off and build your own team in the medium to long term. There’s strong potential for leadership and team growth as the company expands.

We look forward to hearing from you!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Design, and Engineering

Industries

Medical Equipment Manufacturing and Engineering Services