Pr. Quality Systems Specialist
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Must Have: Minimum Requirements
Bachelor’s degree
7+ Years of Quality System experience
• Knowledge in medical device, pharmaceutical and/or a comparable regulated environment.
o FDA regulations (21 CFR 820, 803, 210, 211 and 11), ISO 13485
• Knowledge of root cause investigation and corrective and preventive action execution.
It would be ideal if you also had the following experience:
• Effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
• Product Lifecycle Management (PLM) subject matter expertise
• Experience working with non-conformances, corrective and preventative action and training reports.
• Extensive experience reviewing technical documentation
• Strong written and verbal communication skills
• Ability to educate management in the Audit, CAPA, Configuration Management and Training process areas
• Experience with quality tools and process improvement techniques
• Influence management skills
• Ability to work constructively across all functions/level of the organization as well as external customers and regulators.
Continuous quality improvements are built into our “Quality Begins With Me” culture.
Do meaningful work, make a difference, and improve lives — starting with your own.
Medtronic’s Neurovascular Team in Irvine, CA plays a vital role in improving stroke awareness, prevention and treatment. Our efforts will have lasting impact on countless individuals and families — it is an opportunity we value and take pride in. Together, we can end stroke.
