Quality Engineer

Westmeath  ‐ Onsite
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Description

I have an immediate opening for a Quality Engineer with a growing medical device company based in Athlone. This is a fantastic opportunity to join the company on a permanent basis throughout an exciting growth phase.

The Quality Engineer develops practices and promotes quality principles to achieve specification requirements and required regulatory compliance. The primary responsibilities of this position include assuring: The safety and performance of finished products, the capability of the manufacturing processes and compliance to quality system procedures and external regulatory requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Manufacturing Support*
* Manufacturing Support
* Work with company development groups to facilitate design transfer of new products into manufacturing.
* Ensure manufacturing processes are appropriate and validated for their intended purpose.
* Maintain risk management documentation.
* Monitor process performance to assure capability and prevent non-conformances.
* Ensure test methods are appropriate and validated for their intended purpose.
* Analyze proposed manufacturing or design changes and communicate with divisional functions to determine appropriate validation/verification and documentation requirements.
* Promote the use of best-practice quality and statistical tools.

2. Supplier Support*
* Assist supplier quality engineering in monitoring the performance and qualification of suppliers.
* Assure suppliers corrective actions are initiated and completed.
* Lead First Article Inspection actions as required to support supplier qualification activities.

3. Quality System Support*
* Assure adequate training and compliance to quality system procedures.
* Identify and suggest improvements to quality systems.
* Assist with execution of internal audits to support facility audit schedule.
* Support audits by external agencies as required.

4. Receiving Inspection Support*
* Provide support to Receiving Inspection personnel and process execution.
* Support non-conformance process pertaining to Receiving Inspection.

5 Nonconforming Material Management*
* Investigate nonconforming material events to determine root cause.
* Ensure nonconforming material is properly documented, segregated, labeled and disposition to prevent misuse.
* Assist with investigations on nonconformance's reported via customer complaints.

6. Calibration*
* Support site calibration program.
* Review calibration certification results.

7. Corrective and Preventive Action*
* Lead or support corrective and preventive action process.
* Perform verification of effectiveness for completed CAPA actions.

QUALIFICATIONS:
Education:
* Bachelor's degree in engineering, science or equivalent experience.
Experience:
* Minimum of three years' experience in a like capacity or equivalent within the medical device/pharmaceutical sectors.
* Proven ability to collaborate with teams while assuring compliance.
* Experience with Calibration programs desired.
Skills:
* Knowledge of US 21CFR 820 and ISO13485 quality system requirements.
* Knowledge of statistical methods.
* Knowledge of process validation, IQ/OQ/PQ.
* Ability to read and interpret drawings and specifications.
* Effective written and verbal communication.
* Good interpersonal skills.

If you are interested in this fantastic opportunity please apply directly or contact Derek Sheridan on for immediate consideration
Start date
05/2015
From
Real Staffing
Published at
22.04.2015
Project ID:
890299
Contract type
Permanent
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