Medical Device Software Quality Assurance Specialist

4 weeks ago

Blue Ash, Ohio, United States Diverse Lynx Full time
Software Quality Assurance and Compliance Specialist

Job Summary



We are seeking a highly skilled Software Quality Assurance and Compliance Specialist to join our team at Diverse Lynx LLC. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our medical device software products.



Key Responsibilities




  • Develop, maintain, and continuously improve the software quality capability for medical device and digital products
  • Ensure compliance with procedures and regulatory expectations for existing and new software medical devices and digital products
  • Develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches
  • Advise and educate key functional partners and management on medical device and digital product requirements, standards, and regulations
  • Plan, lead, and execute continuous improvements to the software quality processes
  • Provide independent design review for other software medical device programs
  • Ensure inspection readiness and maintain CE marks for existing software medical devices
  • Employ key company processes to support projects and quality system processes
  • Utilize risk management and risk mitigation tools and practices
  • Conduct reliability assessments of product design
  • Perform root cause investigations using various problem-solving techniques and tools
  • Develop and validate test methods in equipment, process, and product qualifications/validations
  • Implement and/or maintain production and process controls using appropriate techniques


Requirements




  • Minimum 2 years of professional work experience in Quality, R&D, New Product Development, Electrical Engineering, Systems Engineering, Software Engineering, or Computer Science
  • Experience in Quality Engineering or Assurance with a focus on software testing, design control of software development, software verification and validation
  • Knowledge of applied statistics and experience with statistical software applications
  • Knowledge of product/process Risk Management (DFMEA/PFMEA or Gage R&R Analysis, FDA and ISO standards) including cybersecurity assessment
  • Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues
  • Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills
  • Quality Engineering Certification, Software Quality Engineering Certification (e.g., ASQ CQE, ASQ CSQE)
  • Certification (e.g., Black belt) in one or more of the Process Excellence roadmaps (e.g., DMADVV, DMAIC, or Lean)


What We Offer



We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance and compliance, we encourage you to apply for this exciting opportunity.

  • Quality Assurance Specialist

    4 weeks ago

    Blue Ash, Ohio, United States NLign Analytics Full time

    About NLign AnalyticsNLign Analytics is a leading provider of software-based solutions for the aerospace industry. Our unique patented software enables the capture, organization, and visualization of detailed structural inspection and repair data.The PositionWe are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have...

  • Quality Assurance Specialist

    1 month ago

    Blue Ash, Ohio, United States Maverick Molding Full time

    Job OverviewMaverick Molding, a leading manufacturer of high-temperature resins and polymer composites, is seeking a skilled Quality Technician to join our team on the 3rd shift. As a key member of our quality assurance team, you will be responsible for ensuring that our products meet the highest standards of quality and performance.Key...

  • Quality Assurance Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Staffmark Group Full time

    Job Summary:We are seeking an experienced Inspector to join our team at Staffmark Group in Blue Ash, OH. As an Inspector, you will be responsible for performing audits and testing of sub-assemblies and assemblies for acceptable standards of performance using standardized testing equipment.Key Responsibilities:Perform audits and testing of sub-assemblies and...

  • Medical Claims Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Virtual Full time

    Job Title: Medical Billing SpecialistJob Summary: We are seeking a skilled Medical Billing Specialist to join our team at Virtual. As a Medical Billing Specialist, you will be responsible for preparing and submitting medical insurance claims accurately and compliantly.Key Responsibilities:Assign medical codes to diagnoses and procedures for billing...

  • Medical Claims Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Vaco Full time

    Job SummaryVaco is seeking a skilled Medical Billing Specialist to join our team. As a Medical Billing Specialist, you will be responsible for preparing and submitting medical insurance claims accurately and compliantly.Key Responsibilities:Assign medical codes to diagnoses and procedures for billing purposes.Track payments, resolve billing issues, and...

  • IT Support Specialist

    4 weeks ago

    Blue Ash, Ohio, United States ProSource Full time

    The IT Support Specialist role at ProSource is a critical position that requires a strong understanding of computer hardware, software, and networking principles. The successful candidate will be responsible for providing on-site technical support and maintenance for an organization's IT systems and equipment.This includes traveling to various locations to...

  • Senior Software Test Automation Engineer

    3 weeks ago

    Blue Ash, Ohio, United States Eviden Full time

    About the RoleAt Eviden, we're seeking a highly skilled Senior Software Test Automation Engineer to join our team. As a key member of our quality assurance team, you'll be responsible for designing, developing, and maintaining frameworks for our test infrastructure, as well as providing automation expertise to our development teams.The ideal candidate will...

  • Medical Claims Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Vaco Full time

    Job Title: Medical Billing SpecialistVaco Staffing is seeking a Medical Billing Specialist for a contract to hire role in a Hybrid Position. The selected candidate will work 40 hours per week.Key Responsibilities:Prepare and submit medical insurance claims accurately and compliantly.Assign medical codes to diagnoses and procedures for billing purposes.Track...

  • Accounts Receivable Support Specialist

    4 weeks ago

    Blue Ash, Ohio, United States CommuniCare Corporate Full time

    Accounts Receivable Support SpecialistCommuniCare Corporate is seeking a skilled professional to join our Corporate and Field Revenue Cycle team as an Accounts Receivable Support Specialist. This role is responsible for supporting the team in managing and reporting of Clearinghouse, providing backup support to Corp. Revenue Cycle Software Support, and...

  • Accounts Payable Specialist

    3 weeks ago

    Blue Ash, Ohio, United States Vaco Full time

    Accounts Payable Specialist Job SummaryVaco is seeking an experienced Accounts Payable Specialist to join our team in a healthcare setting. As an Accounts Payable Specialist, you will be responsible for ensuring accurate and timely payments to vendors and suppliers, following the healthcare facility's payment policies and procedures.Key...

  • Help Desk Specialist

    1 month ago

    Blue Ash, Ohio, United States Council on Aging of Southwestern Ohio Full time

    Job Title: Help Desk SpecialistCouncil on Aging of Southwestern Ohio (COA) is a nonprofit organization dedicated to enhancing the quality of life for older adults, people with disabilities, and their families. We promote choice, independence, dignity, and well-being through a range of services that help people remain in their homes for as long as...

  • Technical Implementation Specialist

    4 weeks ago

    Blue Ash, Ohio, United States ProSource Full time

    ProSource, the region's leading business technology solutions provider, has been recognized for its commitment to excellence in employee engagement.The company's Top Workplaces 2023 honor by The Enquirer is a testament to its dedication to creating a positive work environment.The anonymous survey conducted by Energage, LLC, measures 15 drivers of engaged...

  • Senior Software Engineer

    4 weeks ago

    Blue Ash, Ohio, United States CommuniCare Family of Companies Full time

    Job Title: Senior Software EngineerAbout the Role:We are seeking a highly skilled Senior Software Engineer to join our team at CommuniCare Family of Companies. As a Senior Software Engineer, you will be responsible for maintaining and enhancing our AI/ML initiatives, leading projects to improve the usability, scalability, efficiency, and security of our AI...

  • Senior Software Developer

    4 weeks ago

    Blue Ash, Ohio, United States Aditi Consulting Full time

    Job Summary:We are seeking a highly skilled Senior Software Developer to lead the development and design of Traceability solutions. The ideal candidate should have expertise in front-end development using React, as well as a strong background in back-end development with Java and Spring Boot. The successful candidate will play a critical role in maintaining...

  • Senior Software Development Lead

    4 weeks ago

    Blue Ash, Ohio, United States Apex Systems Full time

    Job Summary:The Tech Lead for Services Development will play a key role in guiding the direction, development, and delivery of software solutions that meet business needs.This role will be responsible for completing analysis, design, and development tasks required to deliver critical business solutions.The Tech Lead will establish estimates and work plans...

  • Accounts Payable Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Virtual Full time

    AP Specialist Needed for VirtualWe are seeking an experienced Accounts Payable Specialist to join our team at Virtual. The ideal candidate will have a strong background in financial administration, particularly in a healthcare setting.Responsibilities:Process invoices from suppliers and vendors for goods and services.Ensure accurate and timely payments to...

  • Senior Software Engineer, Backend

    4 weeks ago

    Blue Ash, Ohio, United States Fox News Network Full time

    ROLE OVERVIEWAt Fox Tech, we're on the lookout for visionary individuals to join our pioneering team, tasked with shaping the future of streaming products. As a Senior Software Engineer, you'll play a pivotal role in driving the creation of cutting-edge streaming products, translating conceptual ideas into robust, scalable software solutions. Collaborating...

  • Managed Care Contracting Specialist

    4 weeks ago

    Blue Ash, Ohio, United States CommuniCare Family of Companies Full time

    Managed Care Contract Specialist Role SummaryWe are seeking a highly skilled Managed Care Contract Specialist to join our team at CommuniCare Family of Companies. As a key member of our Managed Care & Contracting department, you will be responsible for overseeing strategy and development for all Managed Care Services, Case Management, and Contracting.Key...

  • Divisional EMR Specialist

    1 month ago

    Blue Ash, Ohio, United States CommuniCare Family of Companies Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Divisional EMR Specialist to join our team at CommuniCare Health Services. As a key member of our team, you will be responsible for ensuring compliance with federal and state regulations, as well as maintaining accurate and confidential resident medical records.Key ResponsibilitiesConduct daily,...

  • Intake Specialist

    4 weeks ago

    Blue Ash, Ohio, United States Council on Aging of Southwestern Ohio Full time

    Job Summary:Council on Aging of Southwestern Ohio (COA) is a nonprofit organization dedicated to enhancing quality of life for older adults, people with disabilities, their families, and caregivers. We promote choice, independence, dignity, and well-being through a range of services that help people remain in their homes for as long as possible.As an Intake...