About Abbott

Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world:  in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.

Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.

Job Description:

The Quality Engineer is a member of the Quality Systems department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. The Quality Engineer supports the ID (Infectious Disease) Business Unit’s QMS integration activity across the site to ensure on-going compliance and continuous improvement. The position reports to the Senior Quality Engineer and the role is based in Galway. The Quality Engineer works on complaint activities which support and guide the ID sites in executing their quality and regulatory obligations to ensure a robust and compliant quality management system and audit readiness.  

Responsibilities and Duties:

Support Global Business Unit (BU) in executing on Audit Readiness activities, NC/CAPA records and Supplier Management support to meet corporate and regulatory timelines.Proactively assist the BU and manufacturing sites to investigate and address audit findings, to allow them to reduce/eliminate predictable and repeating findings reoccurring in the future.  Ensure all records meet the required timelines and are fully compliant with our procedures and documented in our quality management system.Support investigations where applicable relating to supplier management activities or defective materials/products.  Work collaboratively with teams across the BU to resolve customer complaints and serve as point of contact for complaints.Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the manufacturing sites within ID.  Possesses and applies a broad and increasing knowledge of Quality, and its application within the ID Business Unit.Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.Develops effective quality metrics and communicates results to key stakeholders. Assists in the preparation and maintenance of records associated with the management review process.Applies problem-solving skills in order to deal creatively with moderately complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration. Update and create quality procedures as required through the change control process.Participate in and support internal and external audits across the BU.Implement the CAPA system ensuring that comprehensive root cause analysis is completed and that corrective and preventative actions are implemented.

Requirements:

Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.Proficient with MS Word, Excel, Power Point, and management of spreadsheets.Able to travel internationally (approximately 10% annually).Experience with CAPA investigation management systems.  

Education & Experience:

Third level qualification in Science/ Engineering.Minimum 5 years of experience in medical device industry with minimum 3 years of progressively responsible positions.Audit experience would an advantage.