Technical Quality Assurance Engineer for Medical Devices
7 days ago
Abbott is a leading healthcare company that empowers people to live their best lives. With a portfolio of life-changing technologies, we serve patients in over 160 countries worldwide.
Job DescriptionWe are seeking a highly skilled Technical Quality Assurance Engineer to join our team in Temecula, CA. This position will be responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.
Duties and Responsibilities- Execute and maintain software quality engineering methodologies
- Provide quality engineering support for software utilized throughout the division
- Work with R&D and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes
- Create and execute or direct software validation protocols traceable to system/software requirements
- Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems
- Assist in the completion and maintenance of risk analysis, focused on software related risks
- Use laboratory test equipment and instrumentation to obtain test data from the devices and be capable of analyzing the data
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues
- Support internal (corporate and divisional) and external quality audits
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
To be successful in this role, you will need:
- Bachelor's degree in Engineering (e.g., Electrical, Computer science, etc.) or Technical Field or equivalent experience
- At least 7 years of Software Quality Engineering experience
- Detailed knowledge of FDA, GMP, IEEE 1012, and ISO 13485
- Advanced computer skills, including statistical/data analysis and report writing skills
- Advanced Information Technology and data mining skills
- Prior medical device experience preferred
- ASQ CSQE certification desired
- Experience working in a broader enterprise/cross-division business unit model preferred
We offer:
- A competitive salary range of $72,700 - $145,300 per year
- Training and career development opportunities
- Financial security through competitive compensation, incentives, and retirement plans
- Health care and well-being programs, including medical, dental, vision, wellness, and occupational health programs
- Paid time off and 401(k) retirement savings with a generous company match
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