Director of Quality & Regulatory - Medical Diagnostics/IVDs

☞ Michael Page

Ver: 106

Dia de atualização: 06-05-2024

Localização: Salem Tamil Nadu

Categoria: Segurança de qualidade / Controle de qualidade

Indústria: Pharmaceuticals Mental Health Care Medical Devices

Posição: Director

Tipo de empregos: Full-time

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Conteúdo do emprego

Director of Quality & Regulatory - Medical Diagnostics/IVDs
  • Leads Quality & Regulatory oversight across organization with growth opportunity
  • Expanding medical diagnostics/IVD company based in Southern NH

    • About Our Client

    This company is a rapidly expanding medical diagnostics/IVD company based in Southern NH. The organization is expanding through customer demand and several key acquisitions. The QA/RA Director will play a key part in integrating Quality Systems as the business makes new acquisitions.

    Job Description

    MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

    Description
    • Lead corporate initiatives to establish and maintain quality assurance and regulatory programs both across and within departments/functions to ensure that responsibilities and procedures for attaining QMS objectives are consistently met.
    • Lead QMS management meetings to review and report on the effectiveness of the QMS.
    • Manages the company’s internal audit program, as required, to determine QMS effectiveness and to assure compliance with the established regulatory requirements.
    • Act at the company’s Quality Management Representative
    • Effectively implement corrective and preventive actions, and corrections, as necessary to address nonconformities and prevent their recurrence.
    • Fulfill medical device reporting requirements (where appropriate) for both FDA and Health Canada.


    The Successful Applicant

    • Degree required: College: Bachelor of Science in engineering or related life science field.
    • Must have experience as a quality engineer/manager in an IVD/medical diagnostics setting.
    • Molecular diagnostics experience preferred.
    • Current ’hands-on’ experience with the majority of the following: CAPA, statistical analysis, establishment and maintenance of Quality Systems, design control, document control, procedure writing, risk management, design review, auditing, verification, validation, process control and improvement.
    • Working understanding of applicable regulatory and industry standards including, but not limited to, ISO 13485, ISO 14971, 21CFR820, IVDD. FDA 510k device submission/approval process a plus.


    What’s On Offer

    • Strong base salary.
    • Annual bonus.
    • Head of Quality/Regulatory position with multiple direct reports with ample opportunity to hire additional headcount.
    • Life-saving device- these products can be found in hospitals which play a fundamental role in preserving life
    • Growth company- this organization is expecting to significantly its size over the next year.
    • Great benefits package - annual bonus, matching 401k, medical, dental, life.


    Contact: Daniel Ferzoco
    Quote job ref: 1532566
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    Data limite: 20-06-2024

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