Quality Engineer - Roscommon

Quality Engineer - Roscommon

Ref No.: SJ4045

Location: Roscommon, Sligo, Leitrim

Salary:

Experience required: 2 - 3 years

Job Type: Permanent



Summary: Our client, a medical device company, is currently recruiting for a Quality Engineer to join their team in Roscommon.Requires a third level degree plus at least 2-3 years relevant experience.



Description:

Our client, a medical device company, is currently recruiting for a Quality Engineer to join their team in Roscommon.

The Quality Engineer has responsibility for the effectiveness of assigned areas of the company's quality system. You will provide quality input and support to the manufacturing and engineering functions.

Principal Duties and responsibilities:

Maintain assigned areas of the quality system in accordance with the requirements of ISO13485, the Medical Device Directive and FDA Quality System Regulations. Includes but not limited to the following:

o Post Market surveillance / Vigilance

o Change control

o Validations

o Risk Management (ISO 14971)

o New Product Introduction

o Technical files / Device Master Files

o Customer complaints / Recalls

o Sterilisation, Sterile product release

Lead and support projects to deliver on new product introductions/product transfers, and process improvements as identified by business needs, which improve quality and efficiency, and reduce costs.

Develop and maintain product Technical files and/or Device Master Files in accordance with MDD and FDA QSR

Coordinate and present periodic Post Market surveillance reports, and review FMEAs in light of these reports.

Complete internal and vendor/contractor audits to monitor the effectiveness of company processes and quality system, and check the level of compliance to the quality system.

Maintain records in accordance with the quality system requirements, which show that products meet the requirements of end users, customers, regulatory authorities and the company.

Review batch records and approve release of product. Release finished product, monitor product sterility and sterilisation records as assigned. Ensure sterilisation cycle is reviewed and current.

Effectively communicate with other staff, customers and suppliers in order to promote awareness of and to conform to customer requirements.

Execute Corrective and Preventive actions as assigned from the company's CAPA System, and disposition non-conforming product. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

Identify areas for improvement and lead improvement initiatives.

Investigate, trouble shoot and report on system failures and product defects. Champion a structured approach to problem solving within process improvement teams.

Investigate, report on, and respond to customer complaints. In conjunction with the Quality Manager, has the authority to initiate product recalls when necessary. Responsible for liaising with competent Authority and Notified Body when necessary.

Maintain the company's validation system. Complete relevant process, product and test method validations supported with appropriate statistical tools.

Requirements:

The successful candidate will have:

A primary degree in quality management, engineering or science.

2 to 3 years medical device/pharmaceutical and/or diagnostics manufacturing experience including practical working knowledge of the MDD, Risk Management ISO 14971, ISO 13485:2003, and FDA QSR is desirable.

A strong technical aptitude is advantageous.

Strong communication, organisational, influencing, analytical, and problem solving skills

Self starter with good inter-personal skills.

Ability to multi-task is essential.

Experience in facilitating FDA and Notified Body audits.