Job Description
Senior Quality Engineer role requires expertise in quality management systems, product quality and compliance, and problem-solving skills to drive compliance and continuous improvement.
Abbott is a global healthcare leader with a diverse range of healthcare products, including diagnostics, medical devices, and nutritionals. Our 109,000 colleagues serve people in more than 160 countries. We operate in Ireland since 1946, with over 6,000 employees across ten sites, including manufacturing facilities and commercial operations.
Abbott Rapid Diagnostics is a part of Abbott's Diagnostics family, bringing together expert teams and industry-leading technologies to support diagnostic testing. Our IDEM business unit supports significant growth for Abbott in COVID-19 related products in over 70 countries.
**Job Description:**
- Ensure quality systems are maintained in compliance with documented procedures, providing guidance and expertise to ensure ongoing compliance and continuous improvement.
- Investigate complex product quality and compliance issues, analyze data, make recommendations, and develop reports.
- Identify deficiencies in quality systems and define systematic corrective actions to support continuous improvement.
- Develop effective quality metrics and communicate results to key stakeholders.
- Apply problem-solving skills to deal creatively with moderately complex situations.
- Drive compliance cross-functionally in alignment with the business unit's 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 business unit.
- Implement the CAPA system, ensuring comprehensive root cause analysis and the implementation of corrective and preventative actions.
- 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 the medical device industry, with at least 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 is 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, PowerPoint, and management of spreadsheets.
- Able to travel internationally (approximately 10% annually).