Graduate, Quality Assurance

The opportunity
Get started on an exciting and meaningful career path with Cook Medical. We love passionate people with great ideas. Our 18-month graduate program in Limerick Ireland provides tailored opportunities to use your qualifications and launch your career while learning and developing new skills.

About Cook Medical
Since 1963 Cook Medical has been finding solutions to improve the worlds healthcare problems for the patients and doctors we serve. As the worlds largest privately owned medical device company we have always operated with our patients customers employees and communities at our core. We do this not only because it is good business but also because we believe that exemplary patient care and being a good corporate citizen is the right thing to do.

Cook Medical has been in Limerick since 1996. Since opening we have become a European headquarters for many of Cooks business functions.
With a global workforce of over 12000 we employ over 950 people in Ireland who bring Endoscopy Urology and Peripheral Intervention products from conception to commercialisation.

Position: Graduate Quality Assurance

Reporting to: Quality Team Lead/ Manager

Responsibilities:

The Quality Assurance function included Quality Engineering Supplier Quality Engineering and the Analytical Laboratory.

As a Quality Assurance graduate you will gain hands-on experience and knowledge as well as having responsibilities in some or all of the following areas: -

Quality Engineering:

• Understand and review Validation documentation Change Requests Design and Process FMEAs Test Summaries Software Validations Microbiological assessments and Critical System Work Orders.
• Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production understanding Design Assurance activities reviewing associated documents including Design Verification/Design Validation Design and Process FMEA Process Validation and Test Summaries.
• Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control In-Process and Final Quality Control.
• Provide input and support to the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process (NCRs).
• Drive digitised data-driven quality by building KPI trending/dashboards and supporting reporting/automation tools to improve visibility and streamline quality workflows.

Supplier Quality Engineering:

• Support the Supplier Appraisal and Approval processes.
• Track supplier quality performance measurements for suppliers (KPIs) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
• Review and approval of raw materials first part approval and supplier process validations.
• Maintaining supplier quality documentation in conjunction with purchasing.

Analytical Laboratory:

• Perform analytical testing in accordance with associated regulatory and procedural requirements and ensure that laboratory documentation is kept up to date at all times
• Daily monitoring and verification of laboratory equipment and completion of associated paperwork.
• Perform instrument calibration and maintenance and review and approval of associated documentation as required.
• Initiate laboratory investigations in a timely manner as required.
• Carry out project work in line with the Lab Strategy with particular focus on the digital transformation
• Comply with GLP/ GMP and safety requirements at all times
• Maintain laboratory in a clean and well organised status at all times

General:

• Initiate manage and execute projects for continuous improvement within the department.
• Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cooks behalf.

Qualifications / Requirements:
Third Level qualification in Science Engineering or a relevant technical discipline.
Previous experience in the medical device industry is desirable but not essential e.g. Co-Op placement intern placement etc.
Ambitious passionate and dynamic individual with a high level of integrity drive and commitment.
A genuine interest in quality and regulatory aspects of the medical device industry.
Demonstrated interest in digitalisation and data-driven quality to support Cooks move toward more digitised quality processes metrics trending and improved visibility through dashboards and streamlined workflows.
Strong Business Analytics and Intelligence skills and an appetite to learn reporting/automation tools
Strong work ethic.
Highly motivated individual self-starter with a passion for excellence.
Excellent communication skills both oral and written
Basic knowledge of medical device quality standards/practises or similar regulated industry.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft Office.
Proven organisational skills.
High self-motivation.
Team Player with ability to develop strong working relationship

#LI-Hybrid #LI-AK1