Operations Quality Engineer Shift Job Description
Job Type: Full-time
About 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.
The Operations Quality Engineer Shift will be responsible for ensuring quality standards are met by analysing quality records, preparing reports and recommending improvements. This role requires the ability to conduct inspections, verifications and validations of components or materials used in development processes.
Key Responsibilities:
- Apply quality principles and analyses quality records to prepare reports and recommend improvements.
- Conduct inspections, verifications and validations of components or materials used in development processes.
- Identify and address recurring problems with the quality of the product or the reliability of testing procedures.
- Document quality issues and performance measures for management review.
- Liaise with external vendors as necessary.
- Monitor and maintain the validation status of site products, processes and systems, including process FMEA and Critical Quality Attribute systems.
- Support equipment and software validation activities and process validation activities.
- Provide regular updates to peers and colleagues on project resource requirements and ensure other quality functions are brought into project teams at appropriate points.
- Report on and support the implementation of actions to reduce the occurrence/reoccurrence of non-conformances within Manufacturing, Product Test and Incoming Material and initiate Exception Reports for discrepancies observed during inspection/testing & review activities.
- Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
- Investigate customer complaints and forward reports to PQA group and responsible for maintaining Corrective and Preventive Action programs.
- Maintain an appropriate balance of quality, compliance and business risk and ensure teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
- Monitor and maintain the quality and compliance status of associated quality records and ensure project teams maintain project records in compliance with Quality System and planned requirements.
- Support DMR change control and calibration activities.
Required Skills and Qualifications:
- Minimum NFQ Level 7 Qualification in Engineering or Manufacturing qualification.
- 3 years experience in a Manufacturing/Science or Engineering environment.
- GMP/GDP experience.
- ISO 13485 experience.
- Yellow belt qualification desired.
Benefits:
- Attractive compensation package that includes competitive pay, family health insurance, excellent pension scheme, life assurance and career development opportunities.
- Fantastic new facility and growing business plus access to many more benefits.
Others:
- Abbott is an equal opportunities employer.