Quality Engineer

MGS are 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.

JOB PURPOSE:

To assist the Quality Operations Manager in the implementation of the MGS Quality Management System. Support the overall quality team in MGS.

RESPONSIBILITIES:

• The Quality Engineer (QE) 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:

• Interfacing with the customer to realise customer satisfaction.

• 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, co-ordinating product/production related NCRs 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 organisations 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 MGS 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 Operations 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.

MGS are an equal opportunities employer.