Senior Quality Assurance Engineer - Lake Forest, CA
•This position is responsible for supporting compliance and quality assurance efforts for new product development and maintaining the quality system for the Surgical Instrumentation Research & Development Quality Assurance team.
- Leads internal audits to ensure regulatory requirements (FDA, MDD, JPAL), standards, and internal procedures are being met.
- Leads quality support for investigations to identify root causes, establishes corrective actions and executes prevention plans for quality system processes.
- Supports R&D in formal structured approach to assist in determining root cause for nonconforming events and evaluate CAPAs for lifecycle effectiveness
- Leads gap assessments and develops compliance plans for third party, regulatory and corporate standards.
- Provides coordination and support for corporate and third party audits/ inspections through preparation, logistical, and tactical activity.
- Monitors R&D quality metrics, and leads quality system continuous improvement projects
- Supports quality system integration for new R&D business units.
- Provides guidance for design control and risk management activities as part of new product development core teams to ensure compliance with regulatory (FDA, MDD, JPAL), local, and corporate requirements and best practices.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor’s degree from an accredited institution in Engineering, preferably Electrical or Mechanical Engineering.
- Minimum 7+ years of experience in regulated industry.
- Minimum 5+ years of experience in Quality System Management
- Minimum 3+ Design Control and Risk Management.
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