Quality Engineer
Abbott
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 113,000 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.
Description
The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of Abbott Rapid Diagnostic’s Quality Management Systems and in moderately complex Quality related projects.
12-month FTC
Responsibilities and Duties
- Possesses and applies a broad and increasing knowledge of Quality, and its application within Abbott Rapid Diagnostic, to the completion of moderately complex assignments.
- Broad knowledge of Abbott Rapid Diagnostic’s organization’s operations and practices to enable informed decisions in day to day operations and assignments.
- Applies problem-solving skills in order to deal creatively with 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. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
- Drives business improvements through continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
Requirements
- Third level qualification.
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions
- 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)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
Minimum Qualifications & Skills
- 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.
Success!
Successfully subscribed for similar jobs
Failure!
- Technical Support Associate - Finnish
Location Ireland - Galway Category Quality
Provide first level support in troubleshooting customer complaints across the designated product range by analysing customer problems and asking the appropriate questions to resolve. The individual wi...
- Quality Engineer
Location Ireland - Galway Category Quality
In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards. Document and execute validation protocols needed...
- QA Team Leader
Location Ireland - Finisklin Category Quality
Ensure prompt attention of a Quality Manager in areas of risk, which might have an adverse effect on product and/or safety. This role reports to our Quality Assurance Manager. You will join the Qualit...
- Regulatory Affairs Specialist
Location Ireland - Galway Category Quality
Minimum of (2) years of experience in Regulatory Affairs role within a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry. Excellent knowledge of Quality/Regulatory requirements in the I...
- Environmental Health & Safety Engineer
Location Ireland - Donegal Town Category Operations
The primary responsibility of the EHS Engineer is to ensure compliance with all relevant Environmental, Health and Safety legislation and assist in developing and maintaining systems and procedures th...