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Sr. Design Quality Engineer

Company: Genalyte, Inc.
Location: San Diego
Posted on: February 24, 2021

Job Description:

Since 2007, Genalyte has been guided by the vision of performing panels of blood tests and receiving results within a few minutes. As we look to the future, Genalyte's technology will transform health care- moving lab testing from the lab into the physician's office.

We are well funded with outstanding growth potential. We are looking for individuals inspired by our technology and vision, who are eager to be at the ground level of this collaborative and entrepreneurial company.

We want to hire individuals who are interested in creating an innovative, fast-paced and dynamic work setting. We offer a competitive salary and benefits package to attract, motivate, and retain the highest caliber of employee.

About the role:

We are seeking a Senior Design Quality Engineer to own all QA design activities in support of our Maverick medical device instrument. The Sr Design QE will support all the development, implementation and continual improvement of the QMS and will work closely with cross functional teams to support all QA activities and initiatives.

Principal Responsibilities

  • Actively participate in product development and design transfer activities for new and existing instrument and consumable products.
  • Lead teams in execution of design control activities with a focus on new product development, quality planning, and risk management to positively impact the safety and efficacy of products.
  • Provide quality oversight and guidance to medical device software, diagnostic instrument, and consumable product realization processes, ensuring adherence to company procedures and applicable ISO 13485:2016 and FDA design control (820.30) requirements.
  • Provide ongoing quality engineering support throughout the product life cycle.
  • Lead and facilitate product and process risk management activities including facilitating risk assessments and FMEA with cross functional teams, maintaining risk management files, and participating in risk analyses associated with design changes, complaint handling, and failure analyses.
  • Provide guidance and support to investigations and corrective/preventive actions related to non-conformances identified through CAPA, post market surveillance, customer feedback, and provide product support as required to determine deficiencies in the quality system, product, and manufacturing processes.
  • Assists with supplier, certification body, and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices implemented by the company.
  • Works independently or with cross-functional teams to lead and support multiple projects, balancing priorities, and resources to meet project and management expectations.

    Qualifications
    • Bachelor's degree or higher in a scientific field, 5+ years related experience, preferably in medical devices, pharmaceutical, or In Vitro diagnostics.
    • Hands-on experience developing and implementing Corrective and Preventive Actions (CAPA) plans, leading Failure Mode Effects Analysis (FMEA), leading root cause analysis (RCA), implementing continual Improvement initiatives and well-versed in problem-solving methodologies (Kaizen, Lean, Six Sigma, etc.).
    • Working knowledge of statistical tools and methodologies used to analyze data.
    • Minimum of 5 years of experience leading internal audits and representing organizations for certification and regulatory body audits. ASQ Certified Quality Auditor certification is desired.
    • Significant experience and knowledge of Quality System Regulations and International Standards such as 21 CFR 11, 21 CFR 820, ISO 13485, ISO 14971, EN 62366, EN62304 and In Vitro diagnostics regulations.
    • Experience leading cross-functional teams including, but not limited to Complaint Handling Units, CAPA Review Boards, Risk Analyses and Assessments, Root Cause and Failure Analyses, and Material Review Boards.
    • Strong verbal and written communication skills.

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Keywords: Genalyte, Inc., San Diego , Sr. Design Quality Engineer, Engineering , San Diego, California

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