Job Description
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.
Benefits:
* 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.
If you are an experienced Quality Engineer looking for a challenging role in the medical device sector, we would love to hear from you. Apply now to join our client's dedicated team in Ashford, Kent.