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Senior Quality Engineer

Company: Selux Diagnostics
Location: Charlestown
Posted on: November 23, 2021

Job Description:

Company DescriptionSelux Diagnostics' platforms will enable clinicians to administer personalized therapies to Infectious Diseases patients within hours rather than days. These advances promise to improve patient care, shorten hospital stays, and combat the growing antibiotic resistance epidemic. Selux's technology offers uncompromised accuracy and an unprecedented speed to results and breadth of menu.The company's Next Gen Phenotyping (NGP) system completes the microbiology laboratory transformation by slashing the time to culture positivity for all samples and incubation during sample transport for integrated health networks. The 55-person company has its initial product in FDA review and anticipates a mid-2022 product launch. Selux is funded with a combination of Federal and private investment and has completed FDA trials and submission. Learn more atwww.seluxdx.com.Current Responsibilities

  • Support the development of Quality infrastructure by working with management on the development and enhancement of critical processes and procedures, as well as training and mentoring less experienced auditing staff
  • Function as primary liaison for third-party design and development partners providing support for development activities, resolve quality issues, ensure appropriate flow down of quality requirements, and enable positive channels of communication.
  • Generate, review, and implement Quality related policy/procedure/ and guideline development
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function at cross functional technical meetings and Reviews)
    • Provide guidance for engineer, software, scientific departments on Medical Device regulations
    • Work with Supply Chain as needed and provide assistance to develop corrective actions
    • Applies knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
    • Performs other duties as requiredEducation and ExperienceMust Haves
      • Bachelor's degree in an engineering or science related field
      • Minimum of 5 years' experience in a Medical Device field
      • Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820)Nice to Haves
        • Previous work in a commercial program
        • Experience working with suppliers and/or contract manufacturers
        • Ability to work effectively within team and across functionsSkills/Competencies
          • Ability to work effectively within team and across functions
          • Effective verbal and written communication skills
          • Knowledge of basic statistical and quality control principals
          • Travel
          • This position can optionally be primarily remote. However the applicant must be able to travel to the Selux office in Charlestown, MA on an occasional and as needed basis, to attend important in-person meetings with Selux employees, partners, or stakeholders, or attend to urgent matters that can only be addressed on site. Selux follows all CDC and state guidelines regarding pandemic precautions to ensure a safe workplace for all its employees.Job Type: Full-timePay: $100,000.00 - $115,000.00 per yearBenefits:
            • 401(k)
            • 401(k) matching
            • Dental insurance
            • Flexible spending account
            • Health insurance
            • Health savings account
            • Life insurance
            • Paid time off
            • Parental leave
            • Retirement plan
            • Vision insuranceSchedule:
              • Monday to FridayWork Location:
                • One locationWork Remotely:
                  • NoWork Location: One location

Keywords: Selux Diagnostics, Boston , Senior Quality Engineer, Engineering , Charlestown, Massachusetts

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