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    Quality Assurance Specialist - Boston, United States - BioTalent

    BioTalent
    BioTalent Boston, United States

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Introduction

    We are working with an innovative medical device company going through tremendous growth. They are seeking a Quality Assurance Specialist with a focus on CAPA and Root Cause Analysis.

    This role will offer you

    · Accelerated career growth on a team with a proven track record for internal growth.

    · Work on state-of-the-art medical devices on the forefront of healing platforms.

    You will be responsible for

    · Oversee CAPA database and assure prompt completion of activities.

    · Assist in investigations related to complaints, process, or material investigations.

    · Assist with, and lead Root Cause Analysis (RCA).

    · Perform standard quality assurance practices as needed.

    · Become the subject-matter-expert.

    You will bring the following

    · BS in engineering or scientific background.

    · Proven track record managing CAPA processes and facilitating change through process improvements.

    · Strong knowledge of quality management systems, regulatory requirements, and industry standards.

    · Proficient in the use of quality tools and methodologies (e.g., statistical analysis, Six Sigma, FMEA).

    · Experience working with Contract Manufacturing Organizations (CMOs) is a plus.

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