Entaco Medical
Quality Assurance Associate
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Company Description
Entaco Medical is a UK-based cleanroom manufacturing partner specialising in subcontract production for the medical device industry and single-use disposables. The company operates under a robust ISO 13485-certified Quality Management System and maintains full FDA registration, ensuring compliance with 21 CFR Part 820 and applicable GMP standards. Entaco Medical supports both low-volume prototyping and full-scale production, offering flexible services that range from end-to-end solutions to targeted support at specific stages of the manufacturing process. The organisation works closely with clients across the UK and Europe who require a reliable partner to scale production, strengthen quality control, and relieve internal operational pressures. Team members join a highly regulated, quality-focused environment dedicated to producing consistent, safe, and compliant medical devices.
The Role
The QA Associate will support the maintenance and continual improvement of the company's Quality Management System (QMS) within a regulated medical-device manufacturing environment.
The role will work closely with Production, Operations and Engineering to ensure that products and processes consistently meet internal procedures, customer requirements and applicable regulatory and quality standards.
A key responsibility of the role will be to plan, coordinate, deliver and maintain quality-related training activities, ensuring that employees are appropriately trained and competent to perform their assigned duties.
The successful candidate will be involved in quality investigations, CAPA, non-conformances, change control, document control, training, audits and continuous improvement activities.
Quality Management System
- Support the operation and maintenance of the company's QMS in accordance with ISO 13485 and applicable regulatory requirements.
- Maintain quality records and ensure activities are completed in accordance with approved procedures.
- Support document and record control, including SOPs, work instructions, forms and quality records.
- Identify opportunities for improvement within the QMS and raise appropriate actions.
- Support the preparation for internal, customer and regulatory audits.
Training & Competency – Key Responsibility
- Take responsibility for coordinating and carrying out quality-related training activities across the organisation.
- Develop and deliver training on SOPs, work instructions, quality procedures, Good Documentation Practice (GDP), quality awareness and other applicable QMS requirements.
- Coordinate training associated with new and revised procedures and documents.
- Identify training requirements arising from changes, CAPAs, non-conformances, audit findings and other quality activities.
- Work with department managers and process owners to ensure personnel receive appropriate training within required timescales.
- Maintain accurate training records within the QMS and internal training matrix.
- Monitor completion of mandatory and quality-related training and follow up overdue training.
- Support the assessment and documentation of employee competency where required.
- Identify recurring training issues or gaps and recommend appropriate corrective actions.
- Ensure training materials are current, controlled and aligned with approved procedures.
- Provide quality induction/training to new employees where required.
- Support the development of a positive quality culture through regular communication and training initiatives.
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Non-Conformance
- Support the investigation and resolution of product and process non-conformances.
- Assist with root-cause investigations using appropriate problem-solving techniques.
- Work with cross-functional teams to identify appropriate corrective actions.
- Ensure investigation and corrective-action records are complete and appropriately documented.
- Identify where additional training may be required as a result of non-conformances or deviations.
CAPA
- Support the creation, investigation and implementation of Corrective and Preventive Actions (CAPA).
- Assist with root-cause analysis and effectiveness checks.
- Monitor CAPA actions and escalate overdue or ineffective actions where appropriate.
- Coordinate or deliver training actions arising from CAPAs.
- Verify that training-related CAPA actions have been completed and appropriately recorded.
Change Control
- Support the assessment and implementation of changes to products, processes, equipment, suppliers and documentation.
- Identify training requirements associated with approved changes.
- Coordinate and/or deliver training associated with revised procedures and processes.
Production Quality
- Provide day-to-day QA support to manufacturing operations.
- Review manufacturing and quality records for compliance with approved procedures.
- Identify trends and recurring quality issues.
- Support investigations into customer and manufacturing quality issues.
- Provide quality awareness and procedural training to manufacturing personnel.
Audits
- Support internal, supplier and external audits.
- Assist in preparing evidence and documentation for regulatory and customer audits.
- Support responses to audit findings and ensure actions are completed within agreed timescales.
- Provide training records and evidence of competency during audits when required.
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Document Control
- Support the creation, review, approval and controlled release of quality documents.
- Ensure obsolete documents are appropriately controlled and removed from use.
- Ensure revised documents trigger appropriate training activities.
- Maintain accurate records demonstrating that affected employees have been trained on revised documentation.
Quality Improvement & Culture
- Promote awareness and understanding of quality requirements throughout the organisation.
- Identify opportunities to improve quality processes and employee understanding.
- Develop and deliver quality awareness sessions and targeted training where appropriate.
Experience
Skills and Abilities (Can Do Criteria):
Essential
- Experience within a Quality Assurance, Quality Systems or Quality Control environment.
- Experience working within a regulated manufacturing environment.
- Experience delivering or coordinating employee training.
- Good understanding of quality systems and controlled documentation.
- Experience with investigations, non-conformances, CAPA or change control.
- Strong communication and presentation skills.
- Good attention to detail and strong written and verbal communication skills.
- Ability to work effectively with Production, Engineering and other cross-functional teams.
Desirable
- Experience within the medical-device or other highly regulated industry.
- Knowledge of ISO 13485.
- Understanding of ISO 14971 / risk management.
- Experience with internal or supplier audits.
- Knowledge of UK MDR, EU MDR and/or FDA requirements.
- Relevant degree or qualification in Engineering, Science, Quality or a related discipline.
- Formal training or presentation qualification would be advantageous.
Key Competencies
- Strong attention to detail
- Confident presenter and communicator
- Ability to deliver effective training to individuals and groups
- Analytical and investigative approach
- Good problem-solving skills
- Ability to interpret procedures and quality requirements
- Ability to identify training needs and competency gaps
- Strong organisational and time-management skills
- Ability to manage multiple quality and training activities simultaneously
- Good documentation and report-writing skills
- Proactive approach to identifying quality and training issues
- Ability to build positive working relationships across all levels of the organisation
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