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Director QA - Post Market Surveillance

Company: CTI Education Group
Location: Northfield
Posted on: February 25, 2021

Job Description:

Job Description - Director QA - Post Market Surveillance (QUA010103) Director QA - Post Market Surveillance ( Job Number: QUA010103 ) Primary Location Medline Industries has an immediate opening for Director QA - Post Market Surveillance based out of our headquarters in Northfield, IL. This position will begin remotely due to COVID-19. The Director QA will be responsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable products and processes for assigned department(s). MAJOR RESPONSIBILITIES:

  • Direct the Post-Market Surveillance Strategy for Medline. This includes complaint intake and output, recall intake and output, MDR data, data analysis, and communication to the relevant product divisions in order to improve our products.
  • Identify trends and actions based upon customer feedback related to surveys, complaints, servicing, reportable events, and dissatisfaction along with any reporting to regulatory authorities as required.
  • Develop and implement strategy for the Quality department(s) based upon Quarterly Management Review.
  • Prepare and deliver Customer presentations.
  • Act as liaison with Senior Leadership of Divisions, Quality and Regulatory, Suppliers, Manufacturing, and/or Operations to ensure all Post-Market data is timely, accurate, and communicated as appropriate.
  • Collaborate with divisional quality, regulatory, and product managers in developing and implementing QA programs.
  • Oversee QSR for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.
  • Management responsibilities include:
    • Typically, manages through multiple Managers. Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability.
    • Strategic, tactical and operational planning (12 + months) for the function or department;
    • Direct budgetary responsibility for one or more departments, functions or major projects/programs;
    • Interpret and execute policies for departments/projects and develops;
    • Recommend and implement new policies or modifications to existing policies;
    • Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Education
      • Bachelor's degree in Engineering, Science, or Technical Field. Work Experience
        • At least 7 years of experience working with QSR/GMP/ISO requirements or other regulated industries.
        • At least 4 years of management experience.
        • At least 3 years of Post Market Surveillance experience to include at least 2 years of experience at a senior or lead level. Knowledge / Skills / Abilities
          • Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
          • Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
          • Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
          • Position requires travel up to 10% of the time for business purposes (within state, out of state and/or internationally). PREFERRED JOB REQUIREMENTS
            • Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.
            • Experience with SAP, ZenDesk, and ETQ-Reliance Medline Industries, Inc. is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Medline is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact VETERANS AT MEDLINE Medline recognizes the experience and dedication veterans bring to the workplace. We take pride in the career paths provided to our employees. Our military employees add tremendous leadership skills and a broad range of talents which help us drive the healthcare solutions needed for today and tomorrow. Medline Matches Job Skills for our Military Veterans to choose from a wide variety of jobs our current Veteran employees have found a great deal of success. Our dedicated Veteran recruitment professionals are ready to work with you to help translate your highly coveted military skills into a results-driven, entrepreneurial, innovative customer-focused role within the open requisitions at Medline.Click here

Keywords: CTI Education Group, Cleveland , Director QA - Post Market Surveillance, Executive , Northfield, Ohio

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