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Quality Engineer

Company: MPS Medical, Inc.
Location: Brea
Posted on: February 19, 2021

Job Description:

Company Description

On December 31st, 2020 Innova Medical, Inc. acquired MPS Medical to expand its U.S production of COVID-19 antigen test kits, producing over 4 million SARS-CoV-2 Antigen Rapid Qualitative Tests per day. Currently, Innova Medical Group, Inc. is the world's largest manufacturer of rapid antigen test kits and leader in COVID-19 testing solutions arena.

Innova Medical Group, Inc. achieves to deliver better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world's most challenging healthcare problems. Alongside of COVID-19 solutions, Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious disease.

In this role the Quality Engineer acts as departmental manager to works with the Quality Assurance department and personnel on the implementation of the Quality Assurance System. Assist MPS to verify Quality Products, on time and within budget.

Job Description

  • Serve as the quality representative during any product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities.
  • Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.
  • Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure.
  • Assist Complaint Handling Department with technical/engineering support regarding customer complaints and product returns. Investigation may involve reviewing manufacturing batch records, vendor component records, MRB records, etc. to determine root cause of product failure.
  • Prepare and report appropriate metrics to executive management.
  • Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed. Qualifications
    • Minimum two year's experience or advanced degree with one year of experience in quality engineering in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent. General knowledge of manufacturing processes such as assembly, packaging, and sterilization required.
    • Excellent understanding of quality system regulations applicable to the design, manufacture and distribution of medical devices or drugs.
    • Solid understanding of investigation techniques including design of experiments and root cause analysis.
    • Demonstrated understanding and application of Quality System Auditing and Analysis
    • Solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis.
    • Excellent project management, organization, writing and presentation skills required.
    • Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.

      Additional Information

      PHYSICAL DEMANDS -Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:
      • Physically able to sit, stand and walk for extended periods of time.
      • Able to move about on foot; walk up and down stairs repeatedly as needed.
      • Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.

Keywords: MPS Medical, Inc., Fullerton , Quality Engineer, Accounting, Auditing , Brea, California

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