QARA Associate

Health Innovation Research Alliance Northern Ireland; Belfast; On-site; GBP 28,000 - 36,000; Full time

Job summary

A healthcare innovation organization is seeking a Quality Assurance Specialist to ensure compliance with quality standards and assist in regulatory affairs. Ideal candidates will have 1-3 years of experience in quality assurance, a related Bachelor's degree, and knowledge of standards like ISO 13485. The role involves performing quality checks, maintaining documentation, and supporting audits in a dynamic team environment.

Benefits

Attractive remuneration package

Qualifications

• Minimum of 1-3 years of experience in quality assurance or regulatory affairs.
• Basic understanding of ISO 13485 and FDA regulations.
• Familiarity with regulatory submission processes.

Responsibilities

• Perform quality checks and ensure compliance with standards.
• Maintain quality assurance documentation and support audits.
• Investigate and resolve quality-related issues.

Skills

Attention to detail

Analytical skills

Communication skills

Education

Bachelor's degree in Life Sciences or Medical Engineering

Tools

Microsoft Office Suite

QMS software

Job description

Perform routine quality checks and assessments on products to ensure compliance with established quality standards and relevant regulatory requirements.

Assist in maintaining and organizing quality assurance documentation, including Standard Operating Procedures (SOPs), work instructions, quality records, and regulatory filings.

Support the preparation and coordination of internal and external audits, including documentation, audit trails, and corrective action responses.

Stay informed about industry regulations, standards, and best practices, particularly in medical device quality and regulatory compliance.

Participate in the creation and maintenance of risk management activities, including risk assessments and mitigation strategies for product-related issues.

Contribute to the development and delivery of training materials on quality management systems (QMS), regulatory standards, and quality assurance processes.

Assist in investigating and resolving quality-related issues, non-conformities, and

customer complaints, ensuring that effective corrective actions are implemented.

Monitor and report on quality performance, identifying trends or issues and working to improve overall product quality.

Support the change control process by evaluating the impact of changes on quality management systems and regulatory compliance.

Ensure compliance with global regulatory requirements for product registration, including supporting the submission process for regulatory approvals.

For this opportunity you should have:

Minimum of 1-3 years of experience in quality assurance, regulatory affairs, or a related field, preferably within the medical device or healthcare industry.

Basic understanding of ISO 13485, FDA regulations, and other industry-specific standards (e.g., MDD, MDR, 21 CFR Part 820).

Bachelor’s degree in a related field (e.g. Life Sciences, Medical Engineering)

Familiarity with regulatory submission processes and documentation.

Experience in assisting with internal audits, CAPA processes, or change control procedures.

Strong analytical skills with the ability to assess regulatory compliance and identify areas for improvement.

Excellent written and verbal communication skills, with the ability to interact effectively across teams.

Attention to detail and ability to work in a fast-paced, deadline-driven environment.

Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint); knowledge of QMS software is a plus.

Location: Belfast, Northern Ireland.

The Opportunity

Axial3D is a rapidly growing and award-winning start-up and its success is built on the desire, determination, and talent of its employees.

It’s a fun and growing team and Axial3D offers the opportunity for your ideas to be implemented and to be recognized and rewarded for your achievements. We are a diverse group of people committed to making a real impact on people’s lives. We build products for everyone and do not discriminate on gender, ethnicity, sexual orientation, religion, civil or family status, age, disability, or race.

This position is ideal for a candidate who wishes to gain exposure and experience in all areas of QARA, and who wishes to work in a thriving, friendly and evolving company.

This position comes with an attractive remuneration package.