Quality Assurance Manager

Qiagen

South Africa
Permanent
Full-time

13 days ago

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 offerAt 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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