Senior Quality Engineer
22 hours ago
About Abbott
Abbott is a global healthcare leader that helps 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 109,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices, and nutritionals products. In Ireland, Abbott employs over 6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, 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.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now supports significant growth for Abbott in COVID-19 related products in over 70+ countries.
12 month FTC
PURPOSE OF THE JOB:
The Senior 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 Senior Quality Engineer supports the IDEM (Infectious Diseases Emerging Market) Business Unit’s QMS integration activity across the site providing guidance and expertise to ensure ongoing compliance and continuous improvement. The position reports to the Quality Systems Manager and the role is based in Galway.
MAJOR RESPONSIBILITIES
1. Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the Galway Legal Manufacturer (LM).
2. Possesses and applies a broad and increasing knowledge of Quality, and its application within the IDEM Business Unit.
3. Investigate complex product quality and compliance issues (e.g. CAPA, non-conformances, audit observations), analyze data, make recommendations and develop reports.
4. Identifies deficiencies in quality systems and defines systematic corrective actions. Supports the continuous improvement of quality system processes.
5. Develops effective quality metrics and communicates results to key stakeholders. Preparation and maintenance of records associated with the management review process.
6. 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.
7. Drives 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 that comprehensive root cause analysis is completed and that corrective and preventative actions are implemented.
11. Train, coach, and guide lower-level employees on routine procedures and processes.
EDUCATION & COMPETENCIES:
1. Third level qualification in Science/ Engineering
2. Minimum 5-10 years of experience in medical device industry with minimum 5 years of progressively responsible positions
3. Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
4. Experience with problem solving and CAPA investigations
5. Audit experience would be an advantage
6. Excellent interpersonal, written and verbal communication skills, including the ability to convey appropriate information with clarity and effectiveness.
7. Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
8. Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
9. Proficient with MS Word, Excel, PowerPoint, and management of spreadsheets.
10. Able to travel internationally (approximately 10% annually)
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