Quality Validation Specialist

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

Who are Advanced Medical Solutions? AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

Job Description

• 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.