Quality Engineer (Medical Devices)

Arevna; Ipswich; On-site; GBP 35,000 - 50,000; Full time

Job summary

Arevna is seeking a Quality Engineer to enhance their Quality and Regulatory functions within the MedTech sector. The role involves ensuring compliance with global standards, supporting product development, and maintaining quality documentation. Ideal candidates will have a strong background in quality assurance, regulatory requirements, and technical documentation, contributing to the company's commitment to high-quality medical equipment manufacturing.

Qualifications

• Solid understanding of EU MDR and UK MDR requirements.
• Proven experience in authoring technical documentation.
• Familiarity with labelling and packaging regulatory requirements.

Responsibilities

• Provide quality and regulatory support to design team.
• Lead creation and remediation of technical documentation.
• Support CAPA investigations and internal audits.

Skills

Quality Tools

Analytical Skills

Communication

Collaboration

Education

Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering

Job description

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Head of Commercial @ Arevna | Delivering high performing teams in MedTech.

Purpose of the Role:

As a Quality Engineer, you will play a key role in supporting and enhancing the Quality and Regulatory functions within the business. This position is focused on ensuring that product development and manufacturing processes meet global regulatory and quality standards. You will work cross-functionally with design, marketing, and compliance teams to ensure robust quality documentation, regulatory submissions, and QMS compliance are consistently maintained.

Main Duties & Responsibilities:

• Provide quality and regulatory support to the design team to ensure documentation meets EU MDR, UK MDR, and ISO 13485 requirements.
• Lead and contribute to the creation and remediation of technical documentation, including authoring essential components of technical files.
• Support the development of regulatory strategy in collaboration with marketing, ensuring timely execution of global product registrations.
• Write, review, and improve procedures, templates, and forms that support the quality and regulatory functions.
• Assist in maintaining and improving the company’s Quality Management System in line with ISO 13485 and ISO 14971.
• Support CAPA investigations, internal audits, and implementation of corrective actions.
• Ensure labelling, Instructions for Use (IFU), and packaging meet global regulatory requirements.
• Stay current with global regulatory intelligence and support the business in maintaining compliance across all markets.
• Assist in quality activities related to product testing, verification, and validation, where appropriate.

Key Focus Areas:

• EU MDR & UK MDR Compliance
• Technical File Creation & Remediation
• Global Regulatory Submissions & Intelligence
• Labelling & Packaging Compliance
• ISO 13485 QMS Development & Maintenance
• CAPA Management & Internal Audit Support
• Risk Management and Usability Documentation (e.g. RMF, CER, PMCF)

Qualifications, Skills, and Experience:

• Solid understanding of EU MDR and UK MDR requirements.
• Proven experience in authoring or leading the development of technical documentation (e.g., Clinical Evaluation Reports, Risk Management Files, PMCF).
• Familiarity with labelling and packaging regulatory requirements.
• Experience with global product registrations and working with notified bodies or regulatory authorities.
• Knowledge of ISO 13485 and ISO 14971 standards.
• Strong communication and collaboration skills with internal teams and external partners.

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.

Responsibilities

• Perform problem identification, resolution, loss reporting and continuous improvement
• Design and implement methods for process control, process improvement, testing and inspection
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 4+ years' of industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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