Director of Quality Assurance

4 weeks ago

Redwood City, California, United States Karius, Inc. Full time
About Karius
Karius is a pioneering life sciences company that is revolutionizing the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're empowering doctors to quickly solve their most complex cases, providing industry partners with unparalleled access to the microbial landscape to accelerate biomarker discovery and clinical trials, and discovering novel microbes to ultimately reduce patient suffering worldwide.

Position Summary
The Director of Quality Assurance will lead all quality activities at Karius, collaborating with cross-functional teams to manage a quality system that supports the company's diagnostic assay development activities, ensuring compliance with FDA-QSR and CLIA/CAP regulations. This individual will define and build the quality team, leading them in the operation and management of the quality function. The ideal candidate will have experience building quality systems from the ground up and be comfortable operating in a fast-paced startup environment.

Key Responsibilities
* Define and build the quality team to achieve company goals
* Lead the implementation, management, and operation of Karius' quality function for compliance with FDA-QSR and CLIA/CAP regulations
* Develop and plan innovative quality and regulatory strategies in life cycle product management for clinical metagenomic tests
* Manage all aspects of the quality assurance lifecycle, including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, corrective and preventive actions (CAPA), and closing
* Promote awareness across the commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified
* Ensure continuous improvement of the QA systems and processes, establishing Key Performance Indicators to monitor compliance and efficiency
* Collaborate with R&D, product, manufacturing, clinical, and regulatory teams to ensure quality standards are integrated throughout the product life cycle
* Work closely with other departments to address quality issues and implement CAPA
* Ensure CAPA identified during audits are commensurate with current industry practices and benchmarks
* Develop Karius' global quality policy & standards, supporting the company mission to deliver unprecedented insight to enable clinicians to make rapid life-saving treatment decisions
* Act as technical expert in quality processes, guiding cross-functional teams in process development, evaluation, and continuous improvement
* Work across teams to ensure efforts are synchronized with Karius quality procedures, resulting in a single harmonized quality function for the company

What's Fun About the Job?
Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Requirements
* 8+ years of Quality Management, Quality Assurance, and Quality Control leadership experience in Diagnostics, Biotechnology, or relatable life sciences fields. Regulatory experience is highly preferred.
* BS in molecular biology, microbiology or related field; advanced degree (MS/PhD) preferred.
* Experience with implementation, management and operation of FDA-compliant and LDT quality systems. ISO 13485 experience a plus.
* Experience in a quality assurance role, bringing an In-Vitro Diagnostic (IVD) product (or products) through the FDA process.
* Experience preparing for and managing audit visits by certification bodies or regulators, demonstrated by successful completion of audits or successful certification.
* Strong understanding of diagnostic assay development and production processes.
* Demonstrated ability to lead cross-functional teams and manage complex projects in a fast-paced startup environment. Excellent communication and interpersonal skills.

Personal Qualifications
* Excellent written and verbal communication skills.
* Ability to proactively communicate in a consistent, clear, and honest manner.
* Flexible and adaptive in a frequently changing environment.
* Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
* Self-motivated with a strong sense of ownership in areas of responsibility.

  • Director of Quality Assurance

    4 weeks ago

    Redwood City, California, United States Karius, Inc. Full time

    About the RoleKarius, Inc. is seeking a highly experienced Director of Quality Assurance to lead all quality activities at our company. This individual will collaborate with all functions to manage a quality system that supports our diagnostic assay development activities, ensuring compliance with FDA-QSR and CLIA/CAP regulations.The ideal candidate will...

  • Executive Director of Quality Assurance

    3 weeks ago

    Redwood City, California, United States Celito Tech, Inc. Full time

    About the RoleCelito Tech Inc. is seeking a highly experienced and strategic Executive Director of Quality Assurance to lead our QA function. This role demands deep expertise in GCP, quality IT, and CSV (Computer System Validation) work. The ideal candidate will excel at managing multiple client engagements, working closely with quality heads at biotech...

  • Quality Assurance Manager

    3 weeks ago

    Redwood City, California, United States TE Connectivity Full time

    Quality Assurance ManagerAt TE Connectivity, we are committed to delivering high-quality products and services that meet the needs of our customers. As a Quality Assurance Manager, you will play a critical role in ensuring that our products and processes meet the highest standards of quality.Key Responsibilities:Develop and implement quality management...

  • Head of Quality Assurance

    4 weeks ago

    Redwood City, California, United States Tesseract Health Full time

    Job Title: Head of Quality AssuranceAt Tesseract Health, we're seeking a highly skilled and experienced Head of Quality Assurance to join our team. As a key member of our leadership team, you will be responsible for ensuring that our medical devices and processes meet FDA regulatory and international requirements, safeguarding patient safety and facilitating...

  • Director of Quality Assurance

    4 weeks ago

    Culver City, California, United States Motorola Solutions Full time

    Job Description:The Director of Quality Assurance will oversee the QA strategy and processes for both hardware and software products at Motorola Solutions. This role requires a strategic thinker with deep expertise in quality assurance practices, experience in managing cross-functional teams, and a strong understanding of the technology landscape.Key...

  • Senior Quality Assurance Automation Engineer

    4 weeks ago

    Redwood City, California, United States C3 AI Inc. Full time

    Job DescriptionC3 AI Inc. is seeking a highly skilled Senior Quality Assurance Automation Engineer to join our team. As a key member of our Engineering, Product Development, QA, Operations, and Customer Services teams, you will be responsible for driving the software quality automation for our existing and emerging products.Reporting to the Director of...

  • Quality Assurance Manager

    3 weeks ago

    Redwood City, California, United States TE Connectivity Full time

    Quality Assurance ManagerAt TE Connectivity, we are committed to delivering high-quality products and services that meet the needs of our customers. As a Quality Assurance Manager, you will play a critical role in ensuring that our products and processes meet the highest standards of quality.Key Responsibilities:Develop and implement quality management...

  • Quality Assurance Manager

    4 weeks ago

    Redwood City, California, United States TE Connectivity Full time

    Quality Assurance ManagerTE Connectivity is seeking a Quality Assurance Manager to oversee the execution of AD&M Quality and achieve world-class business performance. The ideal candidate will have a strong background in quality management, with experience in discrete manufacturing and a proven track record of driving continuous improvement initiatives.Key...

  • Associate Director, Process Development and Documentation, Clinical Quality Assurance

    3 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryWe are seeking an experienced Associate Director, Process Development and Documentation, Clinical Quality Assurance to join our team at Corcept Therapeutics.Key ResponsibilitiesLead and perform day-to-day clinical quality operations and compliance activities related to developing and documenting processes to support the success of clinical studies...

  • Quality Assurance Manager

    4 weeks ago

    Redwood City, California, United States TE connectivity Full time

    Job Title: Quality Assurance ManagerAt TE Connectivity, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our Quality Organization, you will play a pivotal role in ensuring the highest standards of quality in our products and processes.Key Responsibilities:Develop and implement quality management systems to ensure...

  • Head of Quality Assurance

    3 weeks ago

    Redwood City, California, United States TBWA\Chiat\Day Full time

    Job DescriptionHead of QualityAbout the RoleWe are seeking a highly experienced and skilled Head of Quality to join our team at identifeye HEALTH Inc. As a key member of our organization, you will play a pivotal role in ensuring that our medical devices and processes meet FDA regulatory and international requirements, safeguarding patient safety, and...

  • Quality Assurance Specialist III

    4 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Quality Assurance Specialist IIIPulmonx Corporation is seeking a highly skilled Quality Assurance Specialist III to join our team. As a key member of our quality team, you will be responsible for performing inspections and testing activities to ensure the highest quality standards are met.Key Responsibilities:Perform inspections and testing activities to...

  • Quality Assurance Specialist

    4 weeks ago

    Redwood City, California, United States Advantage Technical Full time

    Job Opportunity: We are seeking a highly skilled Quality Technician to support our Quality Assurance team at Advantage Technical.Job Summary: The successful candidate will be responsible for implementing and maintaining quality tools to ensure compliance with FDA and ISO standards. This role involves investigating issues, driving improvements, and applying...

  • Head of Quality Assurance

    4 weeks ago

    Redwood City, California, United States Tesseract Health Full time

    Join Our Mission to Revolutionize HealthcareWe're a pioneering health-tech company, identifeye HEALTH Inc., on a mission to democratize access to health information. Our innovative approach combines laboratory medicine and radiology to enable non-invasive health monitoring for ocular and systemic diseases. We believe in empowering individuals with...

  • Food Safety and Quality Assurance Director

    4 weeks ago

    Culver City, California, United States Michael Page Full time

    Michael Page is seeking a Food Safety and Quality Assurance Director to lead our client's food safety and quality initiatives.Key Responsibilities:Develop and implement food safety and quality systems to ensure compliance with regulatory requirements.Lead the development and implementation of HACCP programs, recall programs, and allergen programs.Conduct...

  • Design Quality Assurance Specialist

    3 weeks ago

    Redwood City, California, United States Nevro Full time

    About NevroNevro is a global medical device company headquartered in California, focused on delivering comprehensive solutions for chronic pain treatment. Our proprietary 10 kHz Therapy has impacted the lives of over 100,000 patients worldwide.Our Comprehensive PlatformNevro's HFXTM spinal cord stimulation platform includes a Senza SCS system and support...

  • Quality Assurance Inspector

    2 months ago

    National City, California, United States SOUTH BAY SAND BLASTING & TANK CLEANING, INC. Full time

    Job Title: Quality Assurance InspectorSOUTH BAY SAND BLASTING & TANK CLEANING, INC. is seeking a highly skilled Quality Assurance Inspector to join our team in San Diego, CA.Job SummaryIn support of the Quality Director or Manager, the Quality Assurance Inspector will assist in the development of Process Control Procedures (PCP) by conducting ship-checks,...

  • Senior Manager, GMP Quality Assurance Lead

    4 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Job Title: Senior Manager, GMP QualityRevolution Medicines is a clinical-stage precision oncology company dedicated to developing innovative targeted therapies for RAS-addicted cancers.We are seeking a highly skilled Senior Manager, GMP Quality to join our team and play a key role in ensuring the quality and compliance of our products.Key...

  • Assistant Program Director

    4 weeks ago

    Redwood City, California, United States Caminar Full time

    Job Title: Assistant Program DirectorJoin Caminar, a leader in providing innovative client-oriented mental health services, as an Assistant Program Director. In this role, you will assist managers with support and supervision of direct service staff, completing assessments, providing individual and family therapy, and training staff.Responsibilities:Complete...

  • Senior Manager, GMP Quality Assurance Specialist

    4 weeks ago

    Redwood City, California, United States REVOLUTION Medicines Full time

    Revolution MedicinesWe are seeking a highly skilled Senior Manager, GMP Quality to join our team at Revolution Medicines. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Provide QA oversight and support for batch disposition, quality record...