Quality Validation Engineer — Medical Devices

Advanced Medical Solutions; Plymouth; On-site; GBP 45,000 - 60,000; Full time

Job summary

Advanced Medical Solutions is seeking a Quality Engineer to own site validation processes and support continual improvement across manufacturing, QA, and R&D. You will drive risk assessments, maintain the QMS, and ensure compliance with medical device standards.

The role requires a degree in Engineering or related fields, experience in regulated environments, and strong communication skills to lead cross-functional teams and audits. Travel to AMS sites and supplier facilities may be required.

Qualifications

• Requires degree level in Engineering, Microbiology, Chemistry or associated fields, or equivalent industry experience.
• Experience in design, manufacturing, validation or quality engineering position (Medical Device experience preferred).
• Working knowledge of and experience in developing and manufacturing product in a regulated environment, preferably medical devices to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC, ISO 13458 and ISO 9001.
• Proficient in Validation processes.
• Will have a fundamental understanding of a quality management system and its development, documentation and implementation.
• Will have working knowledge of risk management, risk assessment tools & techniques and reporting in accordance with ISO 14971 (essential).
• Excellent communication skills; written, verbal and presenting (essential).
• Able to demonstrate achievement and continual improvement against key performance targets and Quality Objectives (essential).
• Ability to develop and implement quality improvement initiatives, including tracking, analysing and reporting on progress and effectiveness (essential).
• Knowledge of and experience in root cause analysis, problem-solving, and quality improvement tools and techniques (essential).
• Able to manage own time effectively, prioritise tasks and deliver to critical deadlines (essential).
• Must be computer literate eg. Microsoft Word, Excel, PowerPoint, Project, Lotus Notes, ERP systems.

Responsibilities

• Develop, generate, maintain and/or documentation to support an effective and compliant Quality Management System, including:
• Product and Process FMEAs / Risk Assessments.
• Medical Device Risk Management Reports and Files.
• Validation schedules, plans and reports.
• Quality Inspection Procedures and Control Plans.
• Sampling Plans.
• Material and Product Specifications.
• Process Flow Charts.
• Quality Systems and Process SOPs and Work Instructions.
• Ownership of the validation process, providing support and guidance to cross-functional teams performing validations. Writing Validation documentation where required.
• Rapid investigation and resolution of customer reported quality issues.
• Initiate, track, report and trend non-conformities.
• Root cause analysis and problem solving for identified nonconformities and facilitate implementation of actions to increase efficiency and further enhance product reliability.
• Provide quality input to new product developments and extensions to existing product lines, identifying product and process CTQ attributes.
• Review and approval of validation deliverables.
• Participate in external audits of AMS from Customers and Regulatory Agencies.
• Comply with and promote health and safety policies in the workplace.
• Establish and maintain strong and effective internal and external customer relationships.
• Work effectively with colleagues to participate and contribute to the successful completion of personal, team and business goals and objectives.
• Maintain an understanding of current Medical Device standards, directives and regulations.
• Monitor, measure and analyse data including product and process capability, to identify process and Quality Management System deficiencies and continuous improvement opportunities.
• Represent AMS Ltd professionally to external customers, suppliers and regulatory bodies.
• Represent the Quality Department at on site and off site meetings as required.
• Travel to other AMS group and Supplier facilities as required.
• Supervise Quality staff as required.

Skills

Validation

Quality management

Communication

Autonomous working

Attention to detail

Flexibility

Problem solving

Education

Degree in Engineering/Microbiology/Chemistry

Tools

Microsoft Word

Excel

PowerPoint

Project

ERP systems

Job description

Advanced Medical Solutions is seeking a Quality Engineer to own site validation processes and support continual improvement across manufacturing, QA, and R&D. You will drive risk assessments, maintain the QMS, and ensure compliance with medical device standards.

The role requires a degree in Engineering or related fields, experience in regulated environments, and strong communication skills to lead cross-functional teams and audits. Travel to AMS sites and supplier facilities may be required.