Quality Assurance Manager

Atlas Endoscopy; Leeds; On-site; GBP 40,000 - 45,000; Full time

Job summary

Join a forward-thinking company as a Quality Assurance Manager in the medical device sector! This role involves ensuring compliance with vital quality standards and regulations, including ISO 13485 and FDA guidelines. You will lead the Quality Management System, coordinate audits, and guide cross-functional teams to maintain product excellence. If you have a passion for quality assurance and a drive for continuous improvement, this is an exciting opportunity to make a significant impact in a dynamic industry. Bring your expertise and leadership skills to a team that values innovation and quality!

Qualifications

• 3+ years in Quality Assurance within the medical device industry.
• Strong knowledge of ISO 13485, MDR, and FDA regulations.

Responsibilities

• Ensure compliance with quality standards and regulatory requirements.
• Develop and maintain the Quality Management System (QMS).
• Lead CAPA process and provide quality assurance guidance.

Skills

Problem-solving skills

Communication skills

Interpersonal skills

Risk management

Continuous improvement

Education

Bachelor’s degree in engineering

Master’s degree in related field

Tools

ISO 13485

Medical Device Regulation (MDR)

FDA regulations

Job description

Job Title: Quality Assurance Manager (Medical Devices)

Location: Leeds (UK)

Job Type: Full-time, on site

Reports to: QARA Director

Salary range: 40,000.00 – 45,000.00 GBP

Job Description:

We are seeking an experienced and highly motivated Quality Assurance Manager to join our team in the medical device industry. The ideal candidate will have extensive experience in ensuring the quality and compliance of medical devices, with a strong background in ISO 13485, Medical Device Regulation (MDR), and FDA regulations. As a Quality Assurance Manager, you will be responsible for leading and overseeing all quality-related activities, ensuring that our products meet regulatory and customer requirements.

Key Responsibilities:

• Ensure adherence to quality standards and regulatory requirements.
• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, MDR, and FDA regulations.
• Coordinate internal and external audits, including preparation, execution, and follow-up activities.
• Oversee product lifecycle quality control, from design and development through to manufacturing and post-market surveillance.
• Ensure compliance with regulatory bodies (FDA, Notified Bodies) and relevant standards, preparing and managing documentation for regulatory submissions.
• Review and approve validation, verification, and test plans to ensure product quality and regulatory compliance.
• Lead the CAPA (Corrective and Preventive Action) process, ensuring timely and effective resolution of non-conformances.
• Provide quality assurance guidance to cross-functional teams, including R&D, manufacturing, and supply chain.
• Stay up to date with the latest industry regulations, standards, and best practices to continuously improve the quality management system.

Key Qualifications:

• Bachelor’s degree in engineering, or related field (Master’s preferred).
• Minimum of 3 years of experience in Quality Assurance, specifically within the medical device industry.
• In-depth knowledge of ISO 13485, MDR, and FDA regulations.
• Proven experience in managing or leading Quality Assurance teams.
• Strong understanding of risk management, CAPA, and product lifecycle management.
• Excellent problem-solving skills with a focus on continuous improvement.
• Strong communication and interpersonal skills, capable of working across multiple departments.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Device