About Us
At Abbott, we help people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our Presence in Ireland
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritionals. We employ over 6,000 people across ten sites in Ireland, with manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, and Sligo.
Abbott Rapid Diagnostics
Abbott Rapid Diagnostics is part of our Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. Our IDEM business unit supports significant growth for Abbott in COVID-19 related products in over 70+ countries.
Job Description
Senior Quality Engineer
The Senior Quality Engineer plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. This includes supporting the IDEM Business Unit's QMS integration activity across the site, providing guidance and expertise to ensure ongoing compliance and continuous improvement.
Key Responsibilities
1. Stay current with external and internal quality systems standards and requirements, providing quality systems support to the Galway Legal Manufacturer (LM).
2. Apply a broad and increasing knowledge of Quality within the IDEM Business Unit.
3. Investigate complex product quality and compliance issues, analyze data, make recommendations, and develop reports.
4. Identify deficiencies in quality systems and define systematic corrective actions, supporting the continuous improvement of quality system processes.
5. Develop effective quality metrics and communicate results to key stakeholders.
6. Apply problem-solving skills to deal creatively with moderately complex situations.
7. Drive compliance cross-functionally in alignment with the Business Unit objective for standardization and collaboration.
8. Update and create quality procedures as required through the change control process.
9. Participate and support internal and external audits across the BU.
10. Implement the CAPA system, ensuring comprehensive root cause analysis and corrective and preventative actions.
11. Train, coach, and guide lower-level employees on routine procedures and processes.
Requirements
* Third level qualification in Science/ Engineering.
* Minimum 5-10 years of experience in medical device industry with minimum 5 years of progressively responsible positions.
* Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations.
* Experience with problem solving and CAPA investigations.
* Audit experience would be an advantage.
* Excellent interpersonal, written and verbal communication skills.
* Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
* Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
* Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets.
* Able to travel internationally (approximately 10% annually).