Lead QA/QMS Engineer

  • location: Saint Louis, MO
  • type: Permanent
  • salary: $110,000 - $130,000 per year
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job description

Lead QA/QMS Engineer

job summary:
Lead QA/QMS Engineer

  • St. Louis, MO (Central West End)
  • Direct Hire
Lead QA Engineer (QMS)

As a Lead QA Engineer at our client, you will be part of the industry-leading team developing software solutions for clinical laboratories. You will establish testing best practices, develop QA/QC processes, manage bug resolution lifecycle in JIRA, and create automated tests for enterprise products used by medical professionals to interpret and report clinical genomics data. Your contributions will enable clinical laboratories and physicians to deliver patient-specific diagnosis and treatments based on an individual's DNA.

Responsibilities

  • Establish and evolve formal QA processes, ensuring that the team is using industry-accepted best practices.
  • Oversee all aspects of quality assurance including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality goals are met.
  • Lead and mentor QA team members, as well as manage outside contract testers.
  • Act as key point of contact for all QA aspects of releases, providing QA services and coordinating QA resources internally and externally.
  • Develop and execute test cases, scripts, plans and procedures (manual and automated).
Required Experience

  • 5+ years of professional QA/QC experience
  • Experience with ISO 13485 & IEC 62304
  • Experience with FDA Regulatory Submissions
  • Experienced with white and black box testing
  • Hardliner about bugs getting fixed
  • Has developed and implemented testing processes and procedures
  • Extensive experience with development and maintenance of automated testing
  • Good knowledge of automation framework. Good debugging and selenium related problem solving skills.
  • Deep understanding of acceptance testing, unit tests, and regression testing
  • Enjoys writing and executing detailed and comprehensive SOPs
  • Exposure to global client and understanding of global work culture.
Preferred Experience

  • Experience with SaaS products and large customer bases
  • Experience with testing of applications in Bioinformatics/Genomic/Clinical research domain.
  • Experience with QMS, CLIA, HIPAA, FDA CFR Part 11 & 820
  • Has experience managing a QA/QC team
Education

  • Bachelors or Masters of Computer Science or related
 
location: Saint Louis, Missouri
job type: Permanent
salary: $110,000 - 130,000 per year
work hours: 8 to 5
education: Bachelors
 
responsibilities:
Responsibilities

  • Establish and evolve formal QA processes, ensuring that the team is using industry-accepted best practices.
  • Oversee all aspects of quality assurance including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality goals are met.
  • Lead and mentor QA team members, as well as manage outside contract testers.
  • Act as key point of contact for all QA aspects of releases, providing QA services and coordinating QA resources internally and externally.
  • Develop and execute test cases, scripts, plans and procedures (manual and automated).
 
qualifications:
Required Experience

  • 5+ years of professional QA/QC experience
  • Experience with ISO 13485 & IEC 62304
  • Experience with FDA Regulatory Submissions
  • Experienced with white and black box testing
  • Hardliner about bugs getting fixed
  • Has developed and implemented testing processes and procedures
  • Extensive experience with development and maintenance of automated testing
  • Good knowledge of automation framework. Good debugging and selenium related problem solving skills.
  • Deep understanding of acceptance testing, unit tests, and regression testing
  • Enjoys writing and executing detailed and comprehensive SOPs
  • Exposure to global client and understanding of global work culture.
Preferred Experience

  • Experience with SaaS products and large customer bases
  • Experience with testing of applications in Bioinformatics/Genomic/Clinical research domain.
  • Experience with QMS, CLIA, HIPAA, FDA CFR Part 11 & 820
  • Has experience managing a QA/QC team
 
skills: Required Experience

  • 5+ years of professional QA/QC experience
  • Experience with ISO 13485 & IEC 62304
  • Experience with FDA Regulatory Submissions
  • Experienced with white and black box testing
  • Hardliner about bugs getting fixed
  • Has developed and implemented testing processes and procedures
  • Extensive experience with development and maintenance of automated testing
  • Good knowledge of automation framework. Good debugging and selenium related problem solving skills.
  • Deep understanding of acceptance testing, unit tests, and regression testing
  • Enjoys writing and executing detailed and comprehensive SOPs
  • Exposure to global client and understanding of global work culture.
Preferred Experience

  • Experience with SaaS products and large customer bases
  • Experience with testing of applications in Bioinformatics/Genomic/Clinical research domain.
  • Experience with QMS, CLIA, HIPAA, FDA CFR Part 11 & 820
  • Has experience managing a QA/QC team

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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