Cordx
Quality Manager
San Diego, California, United States
Sponsorship not specified$100k-$130kDetected 647 days ago
StatisticsComplianceFDA RegulatoryMedical DevicesCommunicationProblem Solving
> stay_score
odds of building a lasting career here
26Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- The Quality Manager, or Quality Assurance Manager, will inspect the final product to make sure it has been built with compliance to legal standards and meets customer expectations.
- A great quality manager is thorough and observant with an eye for detail.
- Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.
Responsibilities
- Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).
- Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department.
- Manage the documentation of the company's quality management system, ensuring compliance with relevant standards and regulations.
- Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.
- Update company documents in accordance with new or revised quality standards, laws, and regulations.
- ISO 13485:2016 lead auditor certification preferred.
Requirements
- Minimum Bachelor's degree in Science or related field.
Compensation
- $100k-$130k
Benefits
- Strong understanding of quality management principles and practices in the medical device industry.
- Minimum 10 Years experience in Medical devices, Quality Management, Regulatory compliance and ISO standards
- Medical Insurance Plan Retirement Plan Paid Time Off Training & Development We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams.
Equal opportunity
- We approach diversity and inclusion seriously and thoughtfully.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.