Senior Supplier Quality Engineer

Abbott Laboratories (Galway, Ireland) 26 days 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 4,000 people across nine 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.

Description

The Senior Supplier Quality Engineer provides a support role to the IDEM Business Unit including Manufacturing Sites and key project activities.    The Senior Supplier Quality Engineer reports to the Quality Operations Manager/Quality Project Lead, IDEM.  The role is based in Galway, Ireland.

This position will have a strong emphasis on driving improvements at suppliers for IDEM sites. The Senior Supplier Quality Engineer will be responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Activities will includes supplier selection, supplier qualification, analysing quality trend data and taking appropriate action; supporting production on all quality related issues; investigating supplier issues; and ensuring an effective and robust quality system which complies with all relevant regulatory requirements

Responsibilities and Duties

  • Possesses and applies comprehensive knowledge of Quality, and its application within Abbott, to the completion of complex assignments.

  • Advanced knowledge of Abbott organization’s operations and practices to enable informed decisions, and providing direction to Quality team and other functional areas.

  • Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.  

  • Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.

  • Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results.  Applies risk assessment techniques in such circumstances. 

  • Independently performs assignments with instruction limited to results expected.  Determines and develops approach to solutions.

  • Drives business improvements through mentoring and support for the continuous improvement initiatives.

  • Escalation point for quality related non-conformances and CAPAs.

  • Drives compliance cross functionally in alignment with the objective for collaboration and multi-site standardisation and compliance.

  • Drives compliance across Business Unit through communication and collaboration to ensure that Quality System requirements are met throughout ARDx. 

Education & Experience Required:

  • Third level qualification.

  • Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;

  • competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),

  • awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)

  • experience in supplier management processes

  • Broad knowledge of engineering and technical applications applied in development of medical devices useful.

  • Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.

  • 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.

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Senior Supplier Quality Engineer

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