Quality Assurance Associate

Location
Cleveland, OH
Category
Full-time
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Description

SUMMARY

  • Entry level role responsible for working with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing, and other company personnel to perform Quality Assurance activities.
  • Works with the team to ensure continued compliance with ISO 13485 and FDA’s Quality Standard Regulation (21 CFR 820).

PRIMARY RESPONSIBILITIES

  • Assist the Field Report Coordinator in the processing of product complaints, including receipt of information from field personnel, completion of reportability decision trees, completion of risk assessments, and review of build documentation.
  • Coordination of product returns associated with product complaints and unused product.
  • Assist with the supplier approval and monitoring program.
  • Initiate and conduct activities associated with the CAPA system. Includes maintenance of CAPA log and ownership of regular team meetings.
  • Support internal, external and supplier audits.  
  • Initiate nonconformances and track activities with assignees to closure.
  • Support periodic management review of quality metrics.
  • Perform incoming, in-process and final inspections according to schedule.
  • Perform or outsource equipment calibration.
  • Review routine change orders for accuracy, effectiveness, compliance, and quality system impact.

ADDITIONAL RESPONSIBILITIES 

  • Remain current with new and changing regulatory requirements, communicate those requirements internally and help implement internal changes as necessary.
  • Assess new and revised standards, guidance materials and regulations for impact upon procedures and design activity. 
  • Participate in the assessment and development of Quality System procedures, work instructions, and processes to ensure efficiency and best quality practices in the development of products, conduct of clinical trials, and production of devices.  
  • Perform document control activities.
  • Attend conferences and seminars to understand and extend company awareness of up-to-date activities in the Quality Assurance field.
Requirements

KNOWLEDGE AND SKILL REQUIREMENTS

Experience, Competencies, Education:

  • Bachelor’s or Associate’s degree in Quality Assurance, Technology, Engineering, Manufacturing, Science and/or another program with additional relevant medical device quality systems experience. 
  • 0-2 years of experience in medical device quality assurance.
  • Strong self-starter, effective team player, and detail oriented.
  • Proficient with MS Office.
  • An effective oral and written communicator and be able to lead meetings and clearly present ideas.

Beneficial Skills and Experience:

  • Understanding of US medical device regulatory compliance requirements (ISO 13485 and FDA’s QSR).
  • Experience in neurostimulation products.

WORKING CONDITIONS

  • Ability and willingness to “get the job done”, allowing for flexible and extended hours, depending upon the project needs
  • Small office environment (does own documentation and interacts directly with others in virtually all situations)
  • Travel will be minimal, and when necessary, can usually be well planned in advance (examples include industry trade meetings, technical training, visits to key supplier sites, etc.)