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Sr Clinical Quality Specialist Job

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Date: Mar 25, 2019

Location: Diegem, BRU, BE

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work. 

About this role:

The Clinical Quality Assurance Specialist position supports the internal clinical quality assurance program and quality systems for the Rhythm Management division of BSC. This includes clinical compliance, quality audits, Inspection Readiness program, and, supporting clinical Corrective and Preventative Action (CAPA) and acquisition integration.

 

Your Responsibilities:

  • Support and mentors the Clinical organization in meeting BSC Quality system requirements
  • Participates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times
  • Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
  • Review, revise, update and maintain Clinical approved vendor list and manages updates to the clinical vendor audit database.
  • Plans, schedules, and conducts external quality assurance audits of the clinical vendors employed in the design, conduct, and analysis of clinical trials.
  • Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed
  • Ensures tracking of audit findings
  • Assists in coordinating regulatory agency sponsor inspections of BSC offices
  • Assists in preparation of investigator sites for Competent Authority or FDA inspections and assists in preparation of written responses to findings
  • Supports the CAPA process, working cooperatively with Clinical owners providing quality input
  • Contributes to the development and or review of clinical and clinical quality procedures and processes
  • Participates in problem-solving with team projects
  • Assists Clinical Quality Assurance Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
  • May support clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements.
  • Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings.

     

     

     

     

    What we are looking for:

    Basic Qualifications:

  • Bachelor’s degree in Life Sciences and 6 years of experience or Master’s degree and 4-7 years of experience
  • Minimum 6 years’ experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; clinical QA and/or compliance experience
  • Minimum 3 years direct clinical quality (GCP) auditing experience
  • Travel up to 50% can be expected including international

     

    Preferred Qualifications

  • Medical device experience desired
  • GCP/auditing certification preferred

     

    Quality System Requirements:

  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

     

     About us

    As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

     

    Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Clinical Quality Specialist


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