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Quality Engineer

Contract Type: Permanent
Location: Unknown
Contact Name: John Philips
Contact Email: john.phillips@rftgroup.ie

Job Description

Quality Engineer

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

JOB PURPOSE:
To assist the Quality Manager in the implementation of the Quality Management
System. Support the overall quality team.

RESPONSIBILITIES:
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