Quality Engineer

Job description

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Abbott in Ireland

In Ireland, Abbott employs almost 3,000 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and third party manufacturing management operations in Sligo. It has commercial and support operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range ofhealth care products includingdiagnostics, medical devices, nutritionals and branded generic pharmaceuticals.Abbott has been operating in Ireland since 1946. 

Abbott Diabetes Care - Donegal

Established in 2006, Abbott Donegal manufactures a range of test strips which are used in Abbott’s blood glucose monitoring meters. The Donegal facility supplies the market needs globally in order to meet the rapid growth in demand due to the increased incidence and detection of diabetes worldwide. The site has undergone considerable development in the past years to upgrade the facility and is expanding its operations presently.

Abbott Diabetes Care Donegal is a premium employer, whilst the Donegal area offers a standard of living that is difficult to equal. This unique location and affordable lifestyle offers an ideal work life balance for those looking for a challenging career within the medical device industry.

Visit Abbott at www.abbott.ie or www.abbott.com and connect with us on Twitter at ************@*******.**

The facility is located on the outskirts of Donegal town and is expanding its operations presently.

Visit Abbott at www.abbott.ie or www.abbott.com and connect with us on Twitter at ************@*******.**

We are currently looking for a Quality Engineer to join Abbott Ireland as follows:

The Quality Engineer is responsible for implementing and maintaining the effectiveness of the quality systems, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance

Major responsibilities:
Initiating Exception Reports for discrepancies observed during inspection / testing & review activities. Preparing and presenting monthly management reports. Investigating customer complaints and forwarding reports to PQA group. Responsible for incoming inspection of raw materials and liaising with vendors on quality issues/performance. Responsible for implementing the site validation and calibration programmes. Ensuring compliance with Abbott policies and procedures regarding the Environment, Health and Safety. Conducting internal audits and external supplier audits & supporting external Reg Audits. Updating Standard Operating Procedures. Responsible for maintaining Corrective and Preventive Action programs. Ensuring product testing is conducted at all stages of manufacturing and coordinating product release documentation. Supporting management in ensuring that the Quality Management System is fully implemented and effective. Working with manufacturing departments to assist in maintaining quality in production. Documentation Control. Performing analysis of chemical raw materials. Conducting calibration (inprocess) of glucose monitoring strips. Performing final inspection of sensor strip lots including documentation review. Final Product Release. Perform the role of study Co-ordinator or Study Staff for In-House Whole Blood Studies.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management

Note: This job description describes the principal and main elements of the job.  It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation.

Minimum education required:

Third level science / engineering or Manufacturing qualification

Minimum experience required:

Two years in a Manufacturing / Science or Engineering environment.

JOB FAMILY:

Quality Assurance-Engineering

DIVISION:

ADC Diabetes Care

LOCATION:

Ireland - Donegal Town

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)