Current jobs related to Director, Quality Assurance - Redwood City - Karius, Inc.
-
Director of Quality Assurance
1 month ago
Redwood City, United States Codexis, Inc. Full timeDepartment 64 - QC & Analytical Development Employment Type Full Time Location Redwood City, CA Workplace type Onsite DescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Director of Quality Assurance. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to...
-
Director of Quality Assurance
4 weeks ago
Redwood City, United States BioSpace, Inc. Full timeJob Details Department 64 - QC & Analytical Development Employment Type Full Time Location Redwood City, CA Workplace type Onsite Description Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Director of Quality Assurance. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology...
-
Director, Quality Assurance Operations Lead
2 weeks ago
Redwood City, California, United States Adicet Bio Inc. Full timeJob SummaryAdicet Bio Inc. is seeking an experienced and motivated Director, Quality Assurance Operations to lead the QA Operations team and establish relationships with internal personnel and external consultants/contractors to support QA activities and responsibilities.Key ResponsibilitiesEnsure Compliance: Ensure current Good Manufacturing Practices...
-
Redwood City, California, United States Pulmonx Full timeJob SummaryThe Vice President, Regulatory Affairs and Quality Assurance will lead the development and implementation of regulatory strategies worldwide to ensure compliance with quality regulations and standards. This role will oversee the preparation of regulatory submissions, manage global licensing and product registration, and interact with regulatory...
-
Director of Quality Assurance
20 hours ago
Kansas City, Missouri, United States Judge Direct Placement Full timeJudge Direct Placement is seeking a seasoned Director of Quality to lead their Quality function in Kansas City, KS. The ideal candidate will have a strong background in biotechnology and experience in directing technical, regulatory, and strategic leadership. They will be responsible for developing and enforcing quality policies and procedures, cultivating a...
-
Director of Quality Assurance
2 weeks ago
Commerce City, Colorado, United States Eleven Recruiting Full timeJob DescriptionEleven Recruiting is seeking a highly skilled Director of Quality Assurance to join one of our top Aerospace Manufacturing clients in Commerce, CA. This role will be responsible for overseeing and advancing the organization's quality assurance and control functions across all operations.This position is crucial in ensuring that products meet...
-
Redwood City, California, United States Pulmonx Corporation Full timeJob SummaryWe are seeking a highly experienced Regulatory Affairs Director to join our team at Pulmonx Corporation. As a key member of our leadership team, you will be responsible for implementing regulatory strategies worldwide to ensure compliance with regulatory requirements and obtain regulatory approval for our products.Key ResponsibilitiesRegulatory...
-
Director Quality Assurance Quality Control
3 months ago
Kansas City, United States Judge Direct Placement Full timeJudge Direct Placement is seeking a degreed Director of Quality in Kansas City, KS! They will be responsible for directing company technical, regulatory/compliance, and strategic leadership for the Quality function. Biotechnology experience required for consideration. The qualified candidate will invent all procedures and policy to cover all aspects of...
-
Director Quality Assurance Quality Control
3 months ago
Kansas City, United States Judge Direct Placement Full timeJudge Direct Placement is seeking a degreed Director of Quality in Kansas City, KS! They will be responsible for directing company technical, regulatory/compliance, and strategic leadership for the Quality function. Biotechnology experience required for consideration. The qualified candidate will invent all procedures and policy to cover all aspects of...
-
Director of Quality Assurance and Control
1 week ago
Kansas City, Kansas, United States Judge Direct Placement Full timeDirector Quality Assurance Quality ControlJudge Direct Placement is seeking a seasoned Director of Quality Assurance and Control to lead our Quality function in Kansas City, KS. As a key member of our team, you will be responsible for directing technical, regulatory, and strategic leadership for Quality. A strong background in biotechnology is essential for...
-
Quality Assurance Specialist
3 weeks ago
Redwood City, California, United States Jobot Full timeFull-Time Quality Assurance Specialist Role in a Leading Medical Device FirmThis position is hosted by Jobot.About Us:We are a distinguished medical device firm located in the region, recognized for our commitment to excellence and our innovative approach. Our core values prioritize our workforce and our clientele, fostering an environment where employees...
-
Quality Assurance Specialist
5 days ago
Redwood City, California, United States Aurora Technologies Full timeAbout Aurora TechnologiesAurora Technologies is a leading technology company that specializes in innovative solutions for the industry. With a strong focus on quality and customer satisfaction, we are committed to delivering exceptional results.Quality Inspector (m|w|d) in Production MonitoringYour ResponsibilitiesYou will work closely with project managers,...
-
Quality Assurance Specialist
3 weeks ago
Redwood City, California, United States Jobot Full timeFull-Time Quality Assurance Specialist Role in a Dynamic Medical Device FirmThis Jobot Job is hosted by: Jake BenyshekAre you a match? Simply apply now by clicking the "Apply Now" buttonand submitting your resume.Salary: $60,000 - $85,000 per yearAbout Us:Located in [City, State] with [# of offices] offices throughout the region, we are a [$Estimated Annual...
-
Quality Assurance Specialist
3 weeks ago
Redwood City, California, United States Cascade Ventures Full timeWe are seeking a Quality Inspector (m/w/d) Software to join our team at Cascade Ventures. As a Quality Inspector (m/w/d) Software, you will be responsible for conducting analyses of the existing infrastructure and collaborating with cross-functional teams (engineers and developers).Key Responsibilities:Conduct thorough analyses of the existing infrastructure...
-
Director of Quality Assurance
2 weeks ago
Tell City, Indiana, United States gpac Full timeGpac is collaborating with a leading food production company that is currently seeking a Quality Assurance Director.This organization is experiencing significant growth and has proven to be resilient, emerging stronger from recent challenges. With two facilities operating around the clock and plans for expansion, they prioritize employee satisfaction and...
-
Quality Assurance Manager
4 days ago
Redwood City, California, United States TE connectivity Full timeJob 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 delivery of high-quality products to our customers.Key Responsibilities:Develop and implement quality management systems to ensure...
-
Director of Quality Assurance
2 weeks ago
Tell City, Indiana, United States gpac Full timeGpac is collaborating with a leading food production company seeking a Quality Assurance Director. This organization is experiencing significant growth and has proven resilient, thriving in the aftermath of recent global challenges. With multiple facilities operating continuously across various shifts, they are committed to providing a rewarding and...
-
Quality Assurance Specialist
4 weeks ago
Redwood City, California, United States Pulmonx Full timeJob Summary:Pulmonx Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and integrity of our medical devices.Key Responsibilities:Perform Inspections and Testing: Conduct thorough inspections and testing activities to ensure compliance with...
-
Quality Assurance Specialist
4 weeks ago
Redwood City, California, United States Jobot Full timeFull-Time Quality Assurance Specialist Role in a Leading Medical Device Firm This opportunity is hosted by Jobot. About Us: We are a top-tier medical device company known for our commitment to excellence and innovation. Our core values prioritize our employees and clients, ensuring a superior experience for all stakeholders. Our reputation has attracted...
-
Director of Quality Assurance
2 weeks ago
Tell City, Indiana, United States gpac Full timeGpac is currently collaborating with a leading food production company seeking a Quality Assurance Director. The organization is experiencing significant growth and has proven resilient, emerging robustly from recent economic challenges. With two facilities operating continuously across three shifts and plans for a third, this is an exciting time to join....
Director, Quality Assurance
3 months ago
Position Summary The Director, Quality Assurance will lead all quality activities at Karius. This person will collaborate with all functions to manage a quality system to support the company's diagnostic assay development activities, ultimately resulting in systems that are both FDA-QSR compliant as well as CLIA/CAP compliant. This person will additionally define and build the quality team, and lead them in the operation and management of the quality function. The ideal candidate will have experience building such systems from the ground up, and be comfortable operating in a fast-paced startup environment.
Why Should You Join Us? Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company's platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Chief Executive Officer *This position is not open to agency support at this time. Agencies, please contact recruiting@kariusdx.com and not the hiring manager for inquiries.
Location: Redwood City, CA
Primary Responsibilities * Define and build the quality team that will be needed to achieve company goals. Lead the implementation, management and operation of Karius' quality function, for compliance with both FDA-QSR and CLIA/CAP/NYSDOH. * 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, issuing CA/PA, 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, by 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 corrective and preventive actions (CA/PA). * Ensure CA/PA identified during audits to address compliance concerns 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. * Lead batch record review, lot disposition, material release, internal audit program, deviation handling, change controls, and quality events processes.
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 across all technical and regulatory dimensions. 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.
Travel: Travel required up to 10%.
Physical Requirements Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.
Position 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 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.
At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual's race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.