Are you a highly motivated individual with a passion for quality assurance and validation? Do you thrive in a fast-paced, dynamic environment and have a keen eye for detail? Look no further! Natera is seeking a CQV Engineer I to join our growing team. In this role, you will play a crucial role in ensuring the quality and performance of our innovative products. If you have a strong background in CQV principles, excellent communication skills, and a desire to make a difference in the healthcare industry, we want to hear from you!
- Conduct quality assurance and validation activities for Natera's products, including developing and executing protocols, analyzing data, and reporting results.
- Collaborate with cross-functional teams to ensure products meet regulatory requirements and industry standards.
- Perform risk assessments and identify potential areas for improvement in product quality and performance.
- Develop and maintain standard operating procedures and protocols for quality assurance and validation processes.
- Communicate effectively with team members and stakeholders to provide updates on project status and address any concerns.
- Utilize CQV principles and methodologies to ensure products meet specifications and function as intended.
- Troubleshoot and resolve any issues related to product quality or performance, working closely with other departments as needed.
- Stay current with industry trends and regulations related to quality assurance and validation.
- Participate in continuous improvement initiatives to enhance overall quality and efficiency of processes.
- Maintain accurate documentation and records of all quality assurance and validation activities.
Bachelor's Degree In Engineering, Biology, Or A Related Field.
Minimum Of 2 Years Experience In The Medical Device, Pharmaceutical, Or Biotechnology Industry.
Knowledge Of Current Good Manufacturing Practices (Cgmp) And Regulatory Requirements (Fda, Iso).
Experience With Equipment And Process Validation, Including Writing Protocols And Reports.
Strong Analytical And Problem-Solving Skills, With The Ability To Troubleshoot And Resolve Technical Issues.
Quality Assurance
Validation
Data Analysis
Problem Solving
GMP
Technical Writing
Compliance
Process validation
Risk assessment
Root cause
Protocol Development
Equipment Qualification
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a CQV Engineer I in Austin, TX, USA is $62,000 - $75,000 per year. This can vary depending on factors such as the specific company, experience level, and education level of the individual.
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Natera is a genetic testing company that operates a CLIA-certified laboratory in San Carlos, California.

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