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Quality Mgt Systems Specialist

Company: KARL STORZ ENDOSCOPY
Location: Auburn
Posted on: January 27, 2023

Job Description:

We are currently seeking a Quality Management Systems Specialist at KARL STORZ. In this role you will primarily be responsible for leading and/or supporting efforts to meet the requirements of FDA/QSR systems, along with continued company growth. Ensure that processes are compliant, effective, and efficient. Leads the department when Quality Manager is absent.

REQUIREMENTS

  • Bachelor's Degree Required.
  • 5 or more years' experience in a Quality Control, Quality Assurance, Continuous Improvement, Process Control, or Manufacturing Engineering is Required.
  • Analytical, written/oral communication, PC, and organizational skills will be essential for successful completion of duties.
  • Experience in an FDA and/or ISO regulated Environment or Medical Devices desirable. Experience with Six Sigma, Kaizen, 5S, or other improvement methodologies a plus.
  • Ability to read blueprints/schematics required. Ability to write specifications a plus.
  • Experience with supplier evaluation and auditing.
    RESPONSIBILITIES
    • All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
    • Own various quality systems which includes responsibilities for writing and revising procedures, ensuring compliance, and establishing and monitoring performance metrics
    • Work to ensure processes are compliant with FDA/QSR and ISO requirements.
    • Monitors quality system performance to compliance with regulations, standards, and the KARL STORZ quality management system.
    • Identify and lead projects to improve process efficiency and effectiveness.
    • Perform analysis, trending, and reporting of non-conformance, and complaint data.
    • Lead and/or assist with efforts to document processes for compliance with FDA/QSR and ISO requirements.
    • Manages the critical suppliers, develops supplier relationships, conducts supplier audits, and monitors and reports supplier performance to management.
    • Reports quality management system performance to management review and takes action items to improve quality management system performance.
    • Monitors and reports on training system to ensure training requirements are identified and personnel are trained in a timely manner.
    • Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
    • This incumbent will work in a typical office environment. May need to spend significant amount of time in operational areas.
    • May need to lift up to 40 lbs.
    • Must be able to use phone and spend lengthy amount of time at computer creating/searching for information.
    • May require frequent travel, up to 25%.
    • Position requires good judgment and decision-making skills.
    • Position requires excellent attention to details.
    • Lead and participate in cross-departmental meetings.
    • Ability to establish strong cross functional relationships
      SAFETY:

      Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all the Company's safety policies and rules. Must be willing to report safety violations and potential safety violations to appropriate supervisory or management personnel.

      QUALITY:

      The incumbent in this position is generally responsible for following FDA/QSR guidelines as described in the procedures related to his/her specific job responsibilities.

      #LI-AA1

Keywords: KARL STORZ ENDOSCOPY, Worcester , Quality Mgt Systems Specialist, Other , Auburn, Massachusetts

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