Quality Engineer

About AMS

**Who are Advanced Medical Solutions?**

When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, it's true. But we're much more than that...
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 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 five 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 and Connexicon, an Irish tissue adhesives specialist. AMS's products, manufactured in the UK, Germany, France, the Netherlands, 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, 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 800 employees.

AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.

Job Details
Reporting to the Quality Manager you will be responsible for quality compliance, technical documentation, project management and co-ordination of projects with other departments.
This job will aid in the maintenance of compliance to relevant cGMP, FDA QSR 21 CFR 820, ISO13485 & European Medical Devices Directive MDD94/42/EEC.
- Maintain and improve quality compliance.
- Validation strategy planning, validation development, validation training and mentoring.
- Identify, manage, and implement continuous improvement initiatives.
- Evaluate product & process risks in line with Medical Device Risk Management requirements.
- New Product/Project Introductions and Validation support, protocol and report approval.
- Test Method Validation, Inspection method, testing equipment qualification (Measurement System Analysis).
- Lead Customer Complaints and CAPA.
- Support Change Control processes

**Key Results Area**:

- Timely resolution of identified non-conformances and implementation of effective corrective action.
- Identification of potential areas of non-conformance and timely action to prevent occurrence.
- Reduction in Quality Management System (QMS) non-conformances, and Customer Complaints & repeat process NC's.
- Timely implementation of product, process, and Quality Management System changes.
- Avoidance of product recalls.
- Compliance with approved procedures.
- Adherence to the QMS, GxP & Regulatory requirements.
Key responsibilities

**What will this role involve?**:

- Develop, generate, and maintain documentation to support an effective and compliant QMS, including:

- Defining requirements and approving Validation activities.
- Product and Process FMEAs / Risk Assessments.
- Customer Complaints.
- Medical Device Risk Management Reports and Files.
- Quality Inspection Procedures and Control Plans.
- Material and Product Specifications.
- Quality Systems and Process SOPs and Work Instructions.
- Supports management and guidance of external and internal audits of the QMS including interfacing with sites and regional competent authorities.
- Support regulatory responses until closure.
- To ensure accuracy of tests results to support acceptance activities.
- To actively participate in the investigation of quality issues and identify effective Corrective and Preventive Actions (CAPA) as required, in a timely manner.
- To generate, update and maintain Quality procedures, test methods, instructions.
- Provides training and mentoring others.
- To review BSI/Compliance Navigator, communicate and influence implementation, as required.
- Develops, analyses, trends, maintains, and reports Quality metrics.
- The jobholder has no budget setting responsibilities.
- Use of various laboratory and computer equipment.
- Review testing activity results against specified acceptance criteria and relevant Out of Specification (OOS) test results, Non-conformances and CAPA's.
- Review and establish requirements for Validation activities.
- Review and assess risk evaluation, change control, QMS documentation.
- Consult with the QM should any test result fail to meet acceptance criteria or anticipated result.
- Determination of priorities at the start of and throughout each shift.
- Escalation to the Quality Manager on the root cause and identified actions arising from non-conformities and OOS results.
- Work closely with Quality, Regulatory, Manufacturing, Supply Chain, and R&D departments.
- Be prepared to work on project teams, participate in quality compliance and continuous improvement team.
- Maintain communication between departments (Quality, R&D and Production) on the status of Quality Projects and Investigations.
- Be an active participant in Departmental, Operational and Project review meetings as required.

**What we're looking for?**:

- Requires degree level education (Engineering, Microbiology, Chemistry, or associated fields), or equivalent experience in design, manufacturing, quality engineering or validation specialist 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/or ISO 9001.
- 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).
- Experience in review of equipment and process validation deliverables (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.
- Must be computer literate eg. Microsoft Word, Excel, PowerPoint, Project, Lotus Notes.
- Ability to represent the department in cross-functional interactions internally and externally.
- Ability to provide solutions to difficult technical issues associated with specific projects.

**Preferred**:

- Experience in medical device industry / Knowledge of ISO13485 & FDA QSR requirements.
- Team supervisory experience.
- Good working knowledge of validation, data integrity, statistics, technical drawing and tolerancing.
- Knowledge of Good Manufacturing Practice, Good Laboratory Practice and Quality Systems.
- Strong attention to detail.
- Familiarity with appropriate software e.g. Minitab, MS Office, Lotus Notes.
- Good organisational skills.
- Ability to identify and implement continual improvement initiatives.
- The Company reserves the right to vary or amend the duties and responsibilities of the post holder at any time according to the needs of the Company's business.
Employment BasisFull Time Location CountryUnited Kingdom Location CityPlymouth Applications Close Date27 Oct 2023