Quality Assurance Engineering Lead
hace 2 días
As a global healthcare leader, we create breakthrough science to improve people's health.
We anticipate changes in medical science and technology to deliver innovative solutions that make a meaningful difference in patients' lives.
Career Development Opportunities:
- An international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
This position works out of our Electrophysiology Division in Costa Rica - Alajuela location.
In Abbott's Electrophysiology business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation.
Our Sr Quality Engineer will be responsible for working closely with Manufacturing and Engineering on sustaining activities to ensure compliance with quality system requirements and achievement of Key Performance Indicators (KPIs).
This includes ensuring NCMR's, MA's, Yield, Cost Reduction projects, etc., and owns/leads process/product validation activities.
Additionally, this role requires working closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtain support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.
This role also involves owning Major Quality System investigations (i.e., CAPAs, HHEs, StopShip, etc.) and audits (External/Internal).
Responsibilities include developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.
This role requires working with minimum supervision and assignments are broad in nature, allowing the employee to use discretion to design project tasks and bring the project to completion.
Key Responsibilities:- Supports technical and statistical investigations concerning optimization and compliance to specification.
- Provides mentorship to lower-level engineering positions.
- Owns measuring process capability, process controls, and process validation/effectiveness.
- Conducts NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations (MA) related to manufacturing Process.
- Supports and leads Major Quality System investigations (i.e., CAPAs, HHEs, StopShip, etc.).
- Bachelor's Degree in Engineering.
- 5-7 years of experience in Quality Engineering positions.
- At least 5 years of experience, with preferably 3+ years in a quality engineering role.
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
- Experience in process improvement tools such as Root Cause Analysis, Fishbone, Is/Is Not, etc., Six Sigma or Process Control & Monitoring (SPC).
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Experience on product and process qualification and validation.
- Project management experience, participating or leading multidepartment project teams.
- Experience on External and Internal audits.
- Provide mentorship to lower-level engineering positions on Technical Writing.
- Advance Command of English / Required / Fluent oral and writing communication including technical writing.
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