Electrophysiology Quality Assurance Specialist
hace 2 semanas
About Abbott Laboratories
Abbott Laboratories is a leading healthcare company that has been making a significant impact on the world of medicine for over 130 years. We are constantly pushing the boundaries of innovation, leveraging breakthrough science to create new solutions that improve people's lives.
A Career with Purpose
We offer a range of exciting opportunities for professionals who share our passion for advancing healthcare. Whether you're interested in research and development, manufacturing, or quality assurance, we have roles available that will challenge and inspire you.
The Opportunity
This position plays a vital role in ensuring the quality of our electrophysiology products. As an Electrophysiology Quality Assurance Specialist, you will be responsible for working closely with our manufacturing and engineering teams to ensure compliance with quality system requirements and key performance indicators. You will also own and lead process/product validation activities, work closely with research and development and regulatory affairs personnel to obtain support on sustaining activities and during new product introduction, and own major quality system investigations and audits.
Key Responsibilities
- Support technical and statistical investigations concerning optimization and compliance to specification.
- Provide mentorship to lower-level engineering/technician positions.
- Own measuring process capability, process controls, and process validation/efforts.
- Conduct NCMR investigations, calibration out-of-tolerance investigations, and complaint investigations (MA) related to manufacturing process.
- Support and lead major quality system investigations (i.e., CAPAs, HHEs, StopShip, etc.).
Requirements
- Bachelor's degree in a STEM field (science, technology, engineering, or math).
- 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 diagrams, IS/IS Not, etc., Six Sigma, or process control & monitoring (SPC).
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Experience in product and process qualification and validation.
- Project management experience, participating or leading multi-departmental project teams.
- Experience in external and internal audits.
- Advanced command of English, including oral and written communication, including technical writing.
Salary Range: $120,000 - $160,000 per year, depending on qualifications and experience.
Benefits
We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and more.
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