Quality Engineer

Matchtech; Ashford; On-site; GBP 55,000 - 63,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Quality Engineer to join their permanent team in Ashford, Kent. The role focuses on ensuring the highest quality standards for medical devices, utilizing quality tools, ensuring compliance with regulations, and collaborating with engineering teams. Ideal candidates will have a strong background in medical device standards and a Bachelor's degree in engineering.

Benefits

Opportunity for career growth

Collaborative work environment

Qualifications

• In-depth knowledge of Quality Management Systems.
• Experience with medical device regulations (ISO 13485, ISO 14971).
• Strong experience in quality audits and risk management.

Responsibilities

• Utilise quality tools and processes to assure product quality.
• Ensure compliance with FDA and other regulatory agencies.
• Collaborate with cross-functional teams on product changes.

Skills

Quality compliance

Analytic thinking

Collaboration

Education

Bachelor's degree in engineering

Job description

Social network you want to login/join with:

Quality Engineer
MEDICAL DEVICES
Ashford Kent
Permanent Position
£55000 to £63000

Key skills required for this role

Medical Devices Quality Engineer R&D

Important

Medical Devices Quality Engineer R&D

Our client, a prestigious player in the life science sector, is seeking a Quality Engineer to join their team in Ashford, Kent. This is a permanent position focusing on ensuring the highest standards of quality for medical devices.

Key Responsibilities:

• Effectively utilise quality tools and processes such as product and process controls, risk analysis and management tools, design verification and validation, and investigations to assure product quality.
• Ensure conformance with regulations of the FDA and other international regulatory agencies, providing responses as necessary.
• Work on advanced design quality engineering projects with input from design quality management.
• Provide compliance guidance for the execution of design verification and validation and maintenance of quality standards within the quality system.
• Develop and maintain product risk management files in line with ISO 14971.
• Apply complex statistical sample size calculations for quality determination on projects.
• Collaborate with cross-functional teams to coordinate product changes.
• Participate in design reviews, test readiness reviews, risk assessments, and design transfers.
• Provide quality support and direction for resolving on-market product issues, escalating to senior management as needed.
• Evaluate, prioritise, and mitigate potential product and process risks to improve product quality.
• Monitor product data to identify statistically significant trends and risks.
• Ensure compliance and consistency with the client's quality system, supporting audit readiness.

Job Requirements:

• Experience in quality compliance, audits, and investigations.
• In-depth knowledge of Quality Management Systems and experience linking risk management to all elements of the quality system.
• Strong knowledge of medical device standards, including ISO 13485 and ISO 14971.
• Experience with and knowledge of FDA, EU MDR, and other key medical device regulations.
• Ability to take a systems approach to understand the interaction between components.
• Analytic thinking skills to identify issues and develop solutions based on data.
• Experience working closely with engineering and manufacturing teams.
• Knowledge in the design, development, and clinical application of respiratory and anaesthesia medical devices is preferred.
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university required.
• ASQ CQE required or ability to obtain within one year.
• Permanent position in Ashford, Kent.
• Opportunity to work in a highly regulated and rewarding sector.
• Collaborative and professional work environment.
• Potential for career growth and professional development.
• Share

manages this role

Matchtech is a STEM Recruitment Specialist, with over 40 years’ experience