Our client is a leading global provider of optimized manufacturing solutions for
high precision medical plastics products with services including: engineering and design-for manufacture; mould-making; sampling & development; injection moulding primarily for the medical device electronics sector; value-added contract manufacturing operations; multi-shot technologies; scalable automation and turnkey manufacturing systems.
We are currently looking for a full time Quality Engineer
To assist the Quality Manager in the implementation of the Quality Management
System. Support the overall quality team.
The Quality Engineer shall be responsible for monitoring the production and
release of finished parts and ensuring quality policies and procedures are adhered
to on a daily basis, in accordance with the requirements of the Quality Management
System. This includes but is not limited to:
• Responsibility for production GMP standards
• Investigation of root cause and following through on effective corrective
actions to prevent re-occurrence for customer and internal quality issues.
• Initiating and completing CAPA actions as required.
• Initiating and completing engineering change request and action as required.
• Initiating and completing non-conformance reports (NCR’s) as required, coordinating product/production related NCR’s to closure in a timely manner
• Establishing and monitoring inspection standards, plans, frequencies and test methods
• Establishing and maintaining FMEA’s.
• Preparing and updating quality system documentation
• Supporting customer and surveillance accreditation audits.
• The quality engineer will perform an active role in quality planning and new
product introduction from a quality perspective
• Have a good working knowledge of quality management systems (Ideally
ISO13485) and other product related regulatory requirements
• Develop strong links with customer organisation’s and other project stakeholders
• Validation experience would be advantageous.
• Performing an active role in further development and continuous improvement of the quality management system.
• Support Operations area projects and initiatives
• The training of new or existing personnel on quality procedures and
documentation; ensuring that production personnel are trained for their tasks
and that procedures are in place.
• Understanding of customer documents i.e. Drawings, Purchase Specification, Quality Agreements etc
• Ensuring that on hold material is dispositioned and actioned from QAHOLD in a timely manner.
• Ensuring that all retained samples are stored correctly, and that sample storage area is maintained.
• Ensuring that all quality records are completed as per company procedure comply with GDP.
• Adherence to incoming control requirements and supporting the SCAR process when required.
• Audit experience advantageous.
• Perform additional duties at the request of the Quality Manager.
The Ideal Candidate will:
• Hold a relevant 3rd level qualification and/or equivalent quality experience (1+
yrs @ similar level) ideally in high volume manufacturing
• Have good communication and interpersonal skills
• Be a team player with the ability to work independently
• Be proactive and solutions driven in their approach