Current jobs related to Quality Assurance Compliance Analyst - San Diego, California - Truvian Sciences
-
Director of Quality Assurance and Compliance
4 weeks ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a Director of Quality Assurance and Compliance, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing...
-
Quality Assurance Specialist
2 weeks ago
San Diego, California, United States Johnson Service Group Full timeJob Title: Quality Assurance AnalystJohnson Service Group is seeking a highly skilled Quality Assurance Analyst to join our team. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Assist with quality system supplier audits and ensure compliance with regulatory...
-
Director of Quality Assurance and Compliance
4 weeks ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic plans...
-
Quality Assurance Specialist
4 weeks ago
San Diego, California, United States Johnson Service Group Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Analyst to join our team at Johnson Service Group. As a Quality Assurance Analyst, you will play a critical role in ensuring the quality and compliance of our medical devices.Key Responsibilities:Assist with quality system supplier audits and ensure compliance with regulatory requirements.Develop,...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CRO**About the Role**We are seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance - CRO. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to...
-
Director of Quality Assurance and Compliance
1 week ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout the Role:As a Director of Quality Assurance and Compliance at Sekisui Diagnostics, LLC, you will play a critical role in ensuring the quality and integrity of our products. You will oversee the development, implementation, and maintenance of quality assurance systems and activities, including the generation and review of documents used in good...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CROProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic...
-
Quality Assurance Compliance Specialist
1 month ago
San Diego, California, United States Innovive Full timeJob Title: Quality Assurance Compliance SpecialistInnovive is a rapidly growing B2B manufacturing company serving the biomedical research industry. We value hard work and credit our team for our success. We are seeking a Quality Assurance Compliance Specialist to contribute to our success through collaboration with suppliers and customers, as well as the...
-
San Diego, California, United States Simply Biotech Full timeJob SummarySimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. This role will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key ResponsibilitiesDevelop and implement strategic plans for quality assurance,...
-
San Diego, California, United States Proven Recruiting Full timeTransformative Leadership OpportunityProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance. This is a unique chance to drive impactful projects, expand your GLP knowledge, and collaborate with a skilled team.Key Responsibilities:Implement an Electronic Document...
-
San Diego, California, United States Simply Biotech Full timeJob Title: Associate Director of QA and ComplianceSimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key...
-
Quality Assurance Manager
3 weeks ago
San Diego, California, United States General Dynamics Full timeJob Title: Quality Assurance Manager Job Summary: General Dynamics Ordnance and Tactical Systems is seeking an experienced Quality Assurance Manager to join our San Diego team. As a Quality Assurance Manager, you will be responsible for developing policies, procedures, and methods to evaluate and improve the quality of products, materials, components, and...
-
San Diego, California, United States Proven Recruiting Full timeDynamic Quality Assurance and Compliance RoleAre you a seasoned professional looking for a new challenge? Proven Recruiting is seeking a highly skilled Associate Director of Quality Assurance and Compliance to join our team. This exciting opportunity offers the chance to expand your knowledge, collaborate with a skilled team, and drive impactful projects.Key...
-
Quality Assurance Analyst
3 days ago
San Francisco, California, United States University of California Full timeJob SummaryThe University of California, San Francisco (UCSF) is seeking a Quality Assurance Analyst to join our team. As a Quality Assurance Analyst, you will be responsible for performing testing of registry software to ensure the efficiency of applications used by the Immunization Branch.Key ResponsibilitiesPerform unit, functional, regression, user...
-
Data Analyst
1 week ago
San Diego, California, United States Empirical Full timeAbout the OpportunityWe are seeking a highly skilled Data Analyst to join our team at Empirical. As a key member of our team, you will be responsible for ensuring the accuracy, completeness, and quality of data across all stages of the data lifecycle.Key Responsibilities:Data validation and functional testingDeveloping automation for ongoing QA...
-
Quality Assurance and Compliance Manager
3 weeks ago
San Francisco, California, United States Allbirds Full timeJob Title: Quality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for leading and elevating our Quality Assurance program to ensure the highest standards of quality and compliance across our products.Key...
-
Quality Assurance and Compliance Manager
2 days ago
San Francisco, California, United States Allbirds Full timeQuality Assurance and Compliance ManagerWe are seeking a proactive, collaborative, and detail-oriented Quality Assurance (QA) and Compliance Manager to lead and elevate the QA program at Allbirds.This key role will oversee the end-to-end quality assurance process-from initial design through product development, manufacturing, and post-purchase analysis.The...
-
Quality Assurance and Compliance Manager
1 week ago
San Francisco, California, United States Allbirds Full timeJob Title: Quality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for overseeing the end-to-end quality assurance process, from initial design through product development, manufacturing, and post-purchase...
-
Quality Assurance and Compliance Manager
4 weeks ago
San Francisco, California, United States Allbirds Full timeQuality Assurance and Compliance ManagerWe are seeking a highly skilled Quality Assurance and Compliance Manager to join our team at Allbirds. As a key member of our Operations team, you will be responsible for overseeing the end-to-end quality assurance process, from initial design through product development, manufacturing, and post-purchase analysis.Key...
-
Quality Assurance Strategist
6 days ago
San Diego, California, United States CorDx Full timeJob DescriptionCorDx is a leading biotech organization dedicated to delivering innovative diagnostic solutions. We are seeking a highly skilled Quality Assurance Strategist to join our team.The successful candidate will be responsible for developing and implementing quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant...
Quality Assurance Compliance Analyst
2 months ago
ABOUT TRUVIAN SCIENCES
Truvian Sciences is at the forefront of transforming blood testing through innovative technology. Our mission is to create an automated benchtop diagnostic system that delivers lab-quality results in just 30 minutes, enabling a wide range of health tests from a single blood sample. We aim to make blood testing accessible and affordable in various settings, including retail and private clinics.
At Truvian, we foster a culture of exploration and empowerment, believing that collaboration among talented individuals can lead to remarkable achievements. Our goal is to empower individuals with their health information, making routine health testing convenient and actionable for today's consumers.
POSITION SUMMARY
We are seeking a Quality Assurance Compliance Specialist to support our evolving quality initiatives. This role is pivotal in deploying and maintaining compliance with Truvian's Quality Management System (QMS), including areas such as Design Control, Risk Management, CAPA, NCR, and Supplier Management. The successful candidate will ensure that our QMS aligns with FDA regulations, ISO 13485 standards, and other relevant international requirements.
KEY RESPONSIBILITIES
- Champion the Quality Management System across the organization.
- Lead the development and implementation of quality management practices based on industry standards.
- Ensure adherence to FDA 21 CFR 820 and ISO 13485 requirements.
- Conduct training and monitor compliance within the team.
- Manage internal and external audits, including corrective and preventive actions.
- Document and analyze processes related to the Quality Management System.
- Report on critical quality metrics to identify improvement opportunities.
- Collaborate with senior management to address compliance risks.
- Work with cross-functional teams to integrate quality considerations into business operations.
- Support the Head of QA/RA in managing audits and training initiatives.
- Conduct regular risk assessments to maintain proactive quality management.
- Review quality documentation to ensure compliance with regulatory standards.
- Promote a culture of continuous improvement within the quality team.
- Represent the organization in quality-related discussions with external stakeholders.
QUALIFICATIONS
The ideal candidate will possess:
- Extensive experience in implementing Quality Management Systems and ISO 13485.
- A bachelor's degree in a relevant technical or scientific field.
- In-depth knowledge of FDA 21 CFR 820 and ISO 13485.
- Strong interpersonal and communication skills to engage with various levels of the organization.
- Excellent analytical and problem-solving abilities.
- A minimum of 5 years of experience in Quality Assurance within the IVD sector.
COMPENSATION
The salary range for this position is $106,000 - $122,000, reflecting factors such as experience, skills, and educational background.
PHYSICAL REQUIREMENTS
- Ability to perform tasks requiring manual dexterity and physical activity.
- Capability to lift and move items weighing over 25 lbs. and occasionally up to 75 lbs. with assistance.
- Regularly required to stand, walk, and engage in various physical activities.
Truvian Sciences is committed to providing equal employment opportunities and fostering a diverse workplace.
