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    Quality Assurance Manager - Johannesburg, South Africa - QIAGEN

    QIAGEN
    QIAGEN Johannesburg, South Africa

    1 week ago

    Default job background
    Regular Full time
    Description

    Overview

    At the heart of QIAGEN's business is a vision to make improvements in life possible.

    We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
    Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
    There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
    If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

    Join us. At QIAGEN, you make a difference every day.

    Position Description

    We are currently searching for a QA Manager (part-time OR full-time) to take on responsibility for the QMS at the QIAGEN South Africa office, from where QIAGEN Medical Devices and In Vitro Diagnostic test products are marketed, sold and serviced.

    The successful candidate will oversee quality assurance and quality improvement at QIAGEN South Africa aligned with QIAGEN's global Quality Management System (QMS) including the development, review, implementation, and communication of all quality processes, and lead the site to ISO13485 certification with support from QIAGENs Global Quality Assurance team. The position will require communication/discussion with authorities (eg. SAHPRA) as well as refinement of the current documentation for the site to ensure compliance and audit readiness. KPIs, metrics, audits etc. will need to be established. Familiarity with local regulatory requirements is required, as will working closely with the global Regulatory Affairs function to ensure the organization is kept aware of any changes to requirements. This would also include other sub-Saharan African territories which are served by the South African organization.

    The position will report into the QIAGEN Global QA function.

    Key responsibilities:

  • Manage the QIAGEN South Africa QMS, in alignment with the QIAGEN Global system leading to acquisition of ISO13485 status for the organization.
  • Ensure compliance with the South African Health Products Regulatory Authority accreditation standards, regulatory standards, and information management policies by providing leadership and guidance to staff to ensure that quality policies, processes and procedures are established, current and adhered to.
  • Ensure compliance with the QMS requirements by the establishment of Quality KPIs and Internal Audits, oversight of training and document control and reporting these into the local management team to drive improvements.
  • Interactions with Regulatory Authorities to maintain knowledge bank of requirements for Sub-Saharan Africa.

    • Position Requirements

    BA/BSc qualification (or equivalent employment experience) required.

    Demonstrable, working knowledge of ISO9001 and ISO13485 certified Quality Systems.

    Qualified and experienced Auditor – preferably Lead Auditor.

    Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits.

    Ability to work cross-functionally and with multinational/cultural teams and individuals.

    Willingness to travel internationally up to 5-10%.

    What we offer

    At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

    QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

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