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Job Description
Senior Quality Engineer plays a key role in ensuring the Quality System functions are maintained in compliance with documented procedures.
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.
Job responsibilities:
- Actively stays current with external and internal quality systems standards and requirements.
- Possesses and applies a broad and increasing knowledge of Quality, and its application within the Business Unit.
- Investigate complex product quality and compliance issues, analyze data, make recommendations and develop reports.
- 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.
- Preparation and maintenance of records associated with the management review process.
- Applies problem-solving skills in order to deal creatively with moderately complex situations.
- Identifies problems and possible solutions and takes appropriate action to resolve.
- Drives compliance cross functionally in alignment with the Business Unit objective for standardization and collaboration.
- Update and create quality procedures as required through the change control process.
- Participate and support internal and external audits across the BU.
- Implement the CAPA system ensuring that comprehensive root cause analysis is completed and that corrective and preventative actions are implemented.
- Train, coach and guide lower level employees on routine procedures and processes.
Requirements:
- Third level qualification in Science/Engineering
- Minimum 5-10 years of experience in medical device industry with minimum 5 years of progressively responsible positions
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations
- Experience with problem solving and CAPA investigations
- Audit experience would be an advantage
- Excellent interpersonal, written and verbal communication skills
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time
- Ability to interact with senior internal and external personnel on significant matters
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets
- Able to travel internationally