Principal Quality Engineer
Abbott
Quality Improvement Specialist
In this role you drive quality improvements for Abbott's medical devices by leading complaint investigations and CAPA efforts. You will liaise with R&D, Operations and other Quality functions to ensure regulatory compliance and robust investigation processes. You'll develop test methods, analyze data, and implement process improvements to reduce issues and meet customer needs. This role offers broad cross-functional impact in a global, mission-driven company with strong development and benefits.
Compensation / Benefits
- Free medical coverage in HIP PPO
- High employer contribution to retirement plan
- Tuition reimbursement and education benefits (FreeU)
- Career development opportunities with international company
- Recognition as a great place to work and diversity initiatives
- Broad learning and development opportunities
Responsibilities
- Lead and mentor cross-functional complaint investigations and CAPA efforts
- Develop test methods to identify root/potential causes of complaints
- Maintain and improve the quality system and investigation processes
- Ensure regulatory compliance in investigations and product improvements
- Set global standards for specifications and drawings highlighting critical quality attributes
- Translate business strategy into actionable objectives and day-to-day activities
- Coordinate with R&D, Operations and other Quality functions as a technical lead
- Disseminate investigation results to SMEs and drive cross-disciplinary action
- Plan and manage projects to meet business objectives and timelines
Key requirements
- BS in Math, Science, or Engineering or equivalent
- Minimum 5 years of Quality experience in FDA/ISO regulated environment
- Strong project management and multi-tasking abilities
- Experience leading teams or projects (preferred)
- Ability to analyze data and interpret results
- Strong communication
- Cross-functional collaboration
- Proactive problem-solving
- CAPA investigations
- Test method development
- Investigation process improvement
Vacancy posted 1 day ago
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