Quality Assurance Strategist

4 weeks ago


San Diego, California, United States CorDx Full time
Job Description

CorDx 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 regulatory requirements. This includes leading and mentoring the quality assurance team, fostering a culture of continuous improvement and accountability.

The ideal candidate will have a strong background in quality management, with a proven track record of successfully managing a quality assurance team in a regulated environment. They will also possess excellent analytical, problem-solving, and decision-making skills, as well as strong communication and interpersonal skills.

Key Responsibilities:

  • Develop and implement quality assurance strategies to ensure compliance with regulatory requirements.
  • Lead and mentor the quality assurance team.
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and lifecycle management.
  • Oversee the maintenance and continuous improvement of the company's QMS.

Requirements:

  • Master's degree in a scientific or engineering discipline.
  • Minimum of 10 years of experience in quality assurance within the IVD Class II devices manufacturing industry.
  • Extensive knowledge of FDA regulations, ISO 13485, and other relevant standards.

Benefits:

  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development


  • San Diego, California, United States CNA Full time

    JOB OPPORTUNITY Senior Underwriting Strategist at CNA Job Summary: We are seeking a highly skilled and experienced Senior Underwriting Strategist to join our team at CNA. As a key member of our underwriting department, you will be responsible for developing and implementing underwriting strategies that drive business growth and profitability. Job...


  • San Diego, California, United States HNTB Full time

    At HNTB, we are seeking a highly skilled Marketing Communications Strategist to join our West Division Marketing Team. This is an excellent opportunity to work with a creative and collaborative group of professionals who specialize in proposal and presentation development, content writing, and graphic design.This role entails being responsible for...


  • San Diego, California, United States Top Dogg Staffing Full time

    Quality Assurance SpecialistThe Position Quality Assurance Specialist (Medical Device-Spine) Medical Equipment / Devices Information Technology - Quality AssuranceFull-time United States - California - San Diego - Vista The Compensation $ 80,000 -$91,000 Benefits - FullRelocation Assistance Available - NoCommission Compensation - No Bonus Eligible - Yes...


  • San Diego, California, United States Kratos Defense & Security Solutions Full time

    Job Summary:Kratos Defense & Security Solutions is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for designing, developing, and executing quality assurance and control systems.Key Responsibilities:Design and develop quality assurance and control systemsImplement quality concepts,...


  • San Diego, California, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a Quality Assurance Specialist to join our team at Insight Global. As a Quality Assurance Specialist, you will be responsible for designing and conducting quality assurance testing to support improvement initiatives for various business systems.Key Responsibilities:* Review requirements and...


  • San Diego, California, United States Delphinus Engineering, Inc. Full time

    Delphinus Engineering, Inc. is seeking a highly skilled Quality Assurance Inspector to join our team. As a Quality Assurance Inspector, you will be responsible for ensuring that our production efforts are compliant with customer directives, requirements, specifications, and the Quality Management System.Key Responsibilities:Enforce the Quality Assurance...


  • San Diego, California, United States Manpower -Professional Full time

    Job DescriptionAt Manpower, we are seeking a meticulous and skilled Quality Assurance Technician – CMM Programmer to join our Quality Assurance team. In this role, you will play a crucial part in verifying that our products meet customer requirements while identifying opportunities for improvement.Key Responsibilities:Develop, maintain, and generate CMM...


  • San Diego, California, United States Wondfo USA Full time

    Job DescriptionWondfo USA is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest quality standards and regulatory requirements.Key Responsibilities:Support and comply with the company's Quality Management System policies...


  • San Diego, California, United States XIFIN Full time

    At XIFIN, we're committed to delivering innovative healthcare solutions that empower our clients to navigate the complexities of the healthcare landscape. As the Director of Software Quality Assurance, you'll play a critical role in ensuring the quality and reliability of our software products.Key Responsibilities:Lead a team of quality assurance...


  • San Diego, California, United States gategroup Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at gategroup. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and safety in our Hot Foods Production department.Key ResponsibilitiesConduct temperature checks on products and ensure compliance...


  • San Diego, California, United States MILLENNIUMSOFT Full time

    Job SummaryAt MillenniumSoft, we are seeking a highly skilled Software Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in software quality concepts and experience in developing, publishing, and implementing test plans.Key Responsibilities Ensures quality is built into software development products by utilizing...


  • San Diego, California, United States Aerotek Full time

    **Quality Assurance Specialist**At Aerotek, we're seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes. Your expertise will be crucial in developing and maintaining CMM programs, performing product...


  • San Diego, California, United States Innoflight LLC Full time

    Job OverviewInnoflight LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in driving quality resolutions and implementing processes to enhance product quality.Key Responsibilities:Supports Quality Initiatives: Collaborate with Quality, Engineering, and Operations...


  • San Diego, California, United States Applied Composites Full time

    Job Summary:Applied Composites is seeking a Quality Assurance Engineer 3 who provides expert knowledge in defining and implementing quality assurance solutions to complex issues. The ideal candidate will ensure high reliability and proper performance per product requirements, analyzing reports and defective products to determine trends and recommend...


  • San Diego, California, United States The Swag Bag Team Full time

    Job OverviewWe are seeking a skilled Quality Assurance Specialist to join our dynamic team at The Swag Bag Team. As a key member of our software development lifecycle, you will play a crucial role in ensuring the quality and reliability of our products.Key ResponsibilitiesReview and analyze system specifications to ensure clarity and understanding of...


  • San Diego, California, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistA medical device enterprise company is seeking a Quality Assurance Specialist to join their team.The Quality Assurance Specialist is responsible for designing and conducting quality assurance testing that supports improvement initiatives for various Business Systems.This team is focused on the Service work stream which...


  • San Diego, California, United States LEAD Staffing Full time

    Job SummaryLEAD Staffing is seeking an experienced Quality Assurance Inspector to join our team in San Diego, CA. As a Quality Assurance Inspector, you will be responsible for conducting in-process and final testing and inspections to ensure compliance with technical requirements for reliability and quality conformance.Key ResponsibilitiesConduct in-process...


  • San Diego, California, United States Kratos Unmanned Systems Full time

    Quality Assurance SpecialistKratos Unmanned Systems, a leading defense technology company, is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for designing, developing, and executing quality assurance and control systems. You will use your expertise and judgment to implement a wide variety...


  • San Diego, California, United States Your Company Name Full time

    Quality Surveyor RoleAt Your Company Name, we are seeking a skilled Quality Surveyor to play a crucial part in ensuring that construction projects meet regulatory standards, client requirements, and quality expectations. Key Responsibilities:Site Inspections: Conduct regular site inspections to assess the quality of construction work, including structural...


  • San Diego, California, United States Inovio Full time

    About INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. Our technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information,...