Quality Validation Specialist

Job Description

Job Details

• Performing Quality Engineering tasks and owning the site level Validation process, ensuring timely completion of Validations and providing support to specific validation owners.
• To support the achievement of measurable continual improvement and quality & regulatory compliance across the business.
• Working with Manufacturing, Supply Chain, Quality Departments & R&D, plus supporting other functions, to;
• Evaluate and improve effectiveness of processes and procedures and efficiency of working to improve cost performance and product yields.
• Maintain and improve quality compliance.
• Identify, manage and implement continuous improvement initiatives.
• Evaluate product and process risks through the application of Medical Device Risk Management requirements.
• Support New Product Introductions.
• Support and progress changes requests.
• Ensure that employees are aware of and have working knowledge of quality and regulatory medical device requirements through the development and delivery of training programmes.
• Management of the on-site validation processes and acting as quality approver of such.

What will this role involve?

• 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.

What we're looking for?

• 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).
• Clean room experience (preferred).
• Certified Six Sigma Green or Black Belt (advantageous).
• 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).
• Excellent communication skills; written, verbal and presenting (essential).
• Able to work autonomously and as part of a multi-disciplinary team.
• Keen attention to detail.
• Flexible and adaptable to changing work environment.
• Must be computer literate eg. Microsoft Word, Excel, PowerPoint, Project, Lotus Notes, ERP systems.

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