About Abbott
Abbott is a global healthcare leader, 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.
Our Mission
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.
Abbott in Ireland
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Purpose of the Job
The Quality Engineer is a member of the Quality department and plays a key role in ensuring that the Quality processes are maintained in compliance with documented procedures. The Quality Engineer supports the Legal Manufacturer Quality Management System to ensure on-going compliance and continuous improvement. The position reports to the LM Quality Manager and the role is based in Galway. The Quality Engineer will work across the Legal Manufacturer QMS.
Responsibilities and Duties:
* Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the Galway Legal Manufacturer (LM).
* Support the Legal Manufacturer in executing on supplier management processes, SCAR investigations, supplier audits, performance monitoring and quality agreements.
* Support the Legal Manufacturer to investigate and address supplier non-conformances, proactively work to reduce/ eliminate repeat issues from suppliers in future.
* Work collaboratively with teams across the BU to leverage existing process and implement improvements.
* Act as the SME for supplier management including audit readiness activity and audit facing activity when required.
* Support the LM in executing on Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines.
* Possesses and applies a broad and increasing knowledge of Quality, and its application within the Legal manufacturer QMS.
* 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.
* Update and create quality procedures as required through the change control process.
* Participate in and support internal and external audits.
Requirements:
* Third level qualification in Science/ Engineering.
* Audit experience would be an advantage.
* Minimum 5 years of experience in medical device industry with minimum 3 years of progressively responsible positions.
* Experience with CAPA investigation management systems.
* Supplier management experience would be an advantage.
* Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.
* 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.
* Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g., ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).