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Quality Systems Program Lead

Company: NeoGenomics
Location: Mission Viejo
Posted on: February 22, 2021

Job Description:

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to become part of a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity. NeoGenomics is looking for a Quality Systems Program Lead who wants to continue to learn in order to allow our company to grow. Nowthatyouknowwhatwe'relookingforintalent,letustellyouwhyyou'dwanttoworkatNeoGenomics: As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory. Position Summary: As aQuality Systems Program Leadyou will be accountable for global oversight of the Non-Conformance (NC), Corrective Action/Preventive Action (CAPA) system, customer complaints, and Management of data across the Quality Management Systems. You will assist with maintaining the global NCEs/CAPA/Customer complaints processes including the monitoring process performance and implementing continuous process improvement. Non-Conformance & CAPA Process Management

  • Assists with daily operational aspects of the Non-Conformance /CAPA Process.
  • Employ risk analysis tools to determine appropriate internal and external corrections required
  • Develop and employ sound investigative techniques to fully understand and document problems
  • Utilize, lead, and facilitate formal Root Cause analysis/techniques
  • Thoroughly document all aspects of the CAPA process to develop an audit ready CAPA record
  • Work with cross-functional teams throughout CAPA process to ensure effective outcomes
  • Complete Quality Management Systems CAPAs in an efficient and effective manner in order to meet the company's metrics for the effectiveness of the CAPA process
  • Coordinate and monitor the Company's CAPA program to assure CAPAs are properly generated, and that corrective or preventative actions are identified and effectiveness checks successfully completed in a time frame consistent with Company policy.
  • Collaborates with the Quality Management team to review and finalize monthly and quarterly NC/CAPA metrics. Run ad hoc reports as necessary.
  • Participates in global site NC/CAPA continuous improvement projects.
  • Determine, Develop, and provide general training to the global NC/CAPA team and other applicable users as necessary.
  • Facilitate training when changes are made to the process, procedure, or MasterControl system.
  • Participates as a NC/CAPA subject matter expert during internal and external audits.
  • Lead the implementation and maintenance of a paperless NC/CAPA process.
  • Lead process performance review meetings with the global NC/CAPA team.
  • May act as delegate to lead Corporate CAPA Review Board meetings.
  • Identify and assist with the implementation of updates to the NC/CAPA MasterControl module; including participating in validation efforts. Management of Quality Management Systems Data
    • Develop and implement data collection systems and other strategies that optimize statistical efficiency and data quality.
    • Acquire data from primary or secondary data sources and maintain databases/data systems.
    • Identify, analyze, and interpret trends or patterns in complex data sets.
    • Interpret data, analyze results using statistical techniques and provide ongoing reports.
    • Management of CAPA Review Board (CRB) and Quality Review Board (QRB), Management Review (MR) data presentations General Quality Management Systems Support
      • Assists in the preparation and execution of site Management Review meetings.
      • Participates as a site internal auditor for the program
      • Maintains good knowledge of laboratory & medical device standards / regulations.
      • Knowledgeable of federal and state laws and regulations concerning clinical laboratory testing procedures and results. (CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820)
      • Responsible for the monitoring, tracking and communication of issues, as well as, documentation of policies and procedures as it pertains to the QMS. Experience & Required Qualifications:
        • Bachelor's Degree, preferably in the Life Sciences, Engineering or an equivalent field of study.
        • Minimum of 3 years of experience performing CAPA investigations, documentation and performing effectiveness verifications of CAPAs.
        • Minimum of 3 years supporting a global Non-Conformance/CAPA process in the medical device or healthcare industry or laboratory Diagnostic industry
        • Experience in FDA regulated industry required, specifically knowledge of applicable regulations, i.e. current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
        • Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
        • Project Management Experience preferred.
        • ASQ Certified Quality Auditor preferred
        • Must exhibit strong and effective communication skills.
        • Must have excellent and effective writing skills.
        • Must be able to maintain a high activity level, and be able to effectively lead and prioritize numerous projects and responsibilities. 5-10% domestic/international with some overnight travel may be required. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status. NeoGenomics endeavors to make www.neogenomics.com/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact our EEO Coordinator at 866-776-5901 option 0 or HR@neogenomics.com . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. Statement to ALL Third-Party Agencies and Similar Organizations: NeoGenomics accepts resumes only from agencies with which we formally engage their services. Please do not forward resumes to our applicant tracking system, NeoGenomics employees or hiring managers, or send to any NeoGenomics facility. NeoGenomics is not responsible for any fees or charges associated with unsolicited resumes. You have been redirected to a NeoGenomics Laboratories job page

Keywords: NeoGenomics, Mission Viejo , Quality Systems Program Lead, Other , Mission Viejo, California

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