Quality Assurance Specialist

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Quality Assurance Specialist

  • Specialty:

    Manufacturing
  • Title:

    Quality Assurance Specialist
    • City:

      Marlborough
    • State:

      MA
    • Zip Code:

      01752-
  • Start date:

    05-03-2019
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    49241

Description

Our client in Marlborough, MA is looking for a Quality Assurance Specialist, on a direct hire basis. This is a great opportunity for someone looking for growth and development. 

Responsibilities:

  • Knowledge of FDA Quality System Regulation, cGMP and ISO 13485: 2016, as they pertain to the medical device industry.
  • Performs product release activities including review of DHRs, sterilization records and post-production release documents.
  • Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action.
  • Review Quality and Operations key performance indicators and support the compliance effort of the Quality team.
  • Creates, controls and maintains training documents and document files.
  • Support and conduct New Employee training and provides training support, as applicable.
  • Collect training records, checks for accuracy, completeness, and obtains corrections when necessary.
  • Reviewing all types of documentation for completeness and accuracy. This includes manufacturing assembly, data calculation and log entries, supplier documents and test documents.
  • Develop and implement quality data reporting and analysis function to support the overall Quality Management System.
  • Provides critical information for audits and reviews/analyzes data and documentation.
  • Identify and address any potential quality impact.

Education & Experience Requirements:

  • Bachelor’s degree (B.S.) or equivalent in related field.
  • 2-3 years related experience in an FDA QSR, cGMP, ISO 13485 compliant environment.
  • Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Production Controls.
  • Prior medical device experience, highly desirable.
  • Experience in a manufacturing facility preferred.
  • Detail-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player.
  • Proven problem-solving skills.
  • Must be able to interpret variety of technical instructions.
  • Advanced skills in Word, Excel and other MS Office applications.
  • Ability to partner effectively throughout the organization to maintain compliance and foster a quality mindset.

#GDMAMFG

#MON

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