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Job Description
About Abbott
At Abbott, we're committed to helping people live their best possible life through the power of health.
For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life.
Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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.
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 problemsolving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearlydefined 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 nonconformances and CAPAs.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multisite ISO13485 certification.
- 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)
- 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.
- Proactive 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.