[15h Left] Senior Quality Engineer
17 hours ago
About Abbott
Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.
Today our 115,000 Abbott colleagues are working to help people live not just longer, but better, in the more than 160 countries we serve.
12 month FTC
Position Summary
The Senior Quality Engineer is a member of the Quality Systems department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. This position is focused on supporting the establishment of Abbott Rapid Diagnostics Galway as a legal manufacturer entity for select on-market and new products. Additionally, this role is focused not only on supporting the implementation & maintenance of Abbott’s Quality System in alignment with applicable regulations and standards including ISO 13485, FDA 21 CFR 820 etc; but also supports activities related to Design Transfer and New Product Introduction (NPI).
Essential Duties and Responsibilities (Key Activities)
- Actively stays current with external and internal quality systems standards and requirements providing quality systems support to the Galway Legal Manufacturer (LM).
- Possesses and applies a broad and increasing knowledge of Quality, and its application.
- Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and NPIs, as assigned.
- Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
- Development and implementation of compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.
- Review and approval of quality system procedures and design records.
- Development and update of associated Risk Management files.
- Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
- Investigate complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations), analyse 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, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve.
- Drives compliance cross functionally in alignment with the business objective for standardization and collaboration.
- Update and create quality procedures as required through the change control process.
- Participate in and support internal and external audits, if required.
- 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.
- Able to travel internationally (if required).
Education / Experience / Skills
- Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
- Minimum 5-10 years of experience in medical device industry with minimum 5 years of progressively responsible positions.
- IVDR, design transfer and new products introduction experience would be an advantage.
- Experience with problem solving and CAPA investigations.
- Excellent interpersonal, written and verbal communication skills, including ability to convey appropriate information with clarity and effectiveness.
- 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 often requiring coordination between organizations.
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP).
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