Quality Engineer

Job Purpose

To maintain and support the quality management systems within a medical device ISO 13485, manufacturing environment.
Maintains product quality standards across all manufacturing processes, focusing on those where deficiencies are known/occur. Supports teams to work accurately and effectively to eliminate/reduce the probability and severity of faults, failures and scrap.
Working as part of a team which strives to define and develop manufacturing solutions from the early phases through to production working with the Engineering team. This will include working as part of a project core team with respect to design control, as well as working with the operational team on continuous improvement projects.

Key Performance Measures

• Environmental monitoring control
• Reporting/completing of quality metrics monthly and filling out dashboard
• Supporting quality control team and monitoring performance and output
• Ensure quality is maintained across manufacturing
• Performing process validations

Key Responsibilities

• Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement.
• Maintaining processes and creating procedures related to incoming inspection, quality assurance and quality compliance.
• Work with the Technical teams to ensure the proper deployment of Engineering Changes.
• Plan and carry out Process Validation for existing and new products.
• Qualified as an internal auditor. Part of the internal quality audit team by auditing the quality and manufacturing processes to ensure both internal and external regulations.
• Maintain working knowledge of Regulatory and Quality System requirements.
• Support customer & 3rd party audits, including yearly QMS audit.
• Writing and updating documentation for maintenance of the quality management system.
• Contribute to CAPA system, complaint management process and documentation control.
• Train and provide assistance to the other QA teams on quality procedures, protocols, and documentation.
• Coordinate investigation of quality issues with customers and suppliers
• Assist with the monitoring, measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised
• Leads Quality related projects and represents quality as and when required on projects across operations

Decision Making

• Works with minimal supervision, taking personal responsibility for own actions and for the quality and accuracy of the work that is produced
• Uses personal judgement and initiative to develop effective and constructive solutions to challenges and obstacles
• Applies the tools within the relevant quality standards and procedures confidently within their role as specialist

Communication & Contacts

• Builds strong relationship across the wider team to share good practice, updates and learnings
• Has a strong understanding of the importance of working with a diverse range of stakeholders
• Confident in preparation and presentation activities

People Management

• Gives feedback and support to Prima employees. Excellent written and verbal communication skills

Financial Responsibility

• Contribute to budgeting for the quality department overall budget
• Costing and invoicing of services required to aid in carrying out your role


• All employees are responsible for the care and safekeeping of all company equipment as appropriate to their role
• Issues requiring training and/or qualification not undertaken/held by the employee must be escalated to the correct person
• Untrained/unqualified employees are forbidden from undertaking the use or maintenance of equipment

Qualifications & Experience

• Scientific or engineering degree with experience in the medical device or pharma industry, in a quality related position.
• Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
• Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745.
• Project management desirable
• Formulating and execution of corrective action programs
• Superb computer competence, including experience with databases and Microsoft Office
• Knowledge of QA terms, tools, and methodologies

Personal Qualities

• Analytical skills – Ability to interpret data, spotting trends and planning corrective actions
• Organisational skills – Track testing results, documentation, and recommendations
• Excellent written communication – concise and accurate written documentation is essential. Also required to review internal and external guidance, and potentially write company SOPs
• Interpersonal skills – Able to provide training to staff on quality systems, working closely with manufacturing team members to find and eliminate errors in the processes
• Attention to detail – must be able to audit processes for non-compliance. Provide guidance and solutions for non-conformities. Ability to read and interpret the details of external guidance and industry regulations
• Critical/logical thinking – Ability to identify problems and solutions to ensure efficiency and quality of the manufacturing process

Working Environment and Context

• This role is predominately office based (with some remote working available)
• The nature of the work requires a willingness to undertake national and international travel and have a flexible approach to working hours
• Working within the manufacturing environment will be required

Closing Date:  30 April 2022

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