Regional Market Quality Leader - South Africa
A vacancy has been announced for a Regional Market Quality Leader - Middle East with a global technology company entering the medical device space. The position, based in South Africa, is an exciting opportunity to join an innovative and entrepreneurial organisation to provide expertise and bolster a career in the medical device sector.
- Implements and oversees the ASP Quality Management System and its integrated programs within the respective region, such as quality systems training, internal audits, nonconformances, corrective and preventive action, records management, field actions, supplier quality management, procurement, servicing, distribution, and post market surveillance.
- Assures compliance with applicable regulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA.
- Maintains, sustains, and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.
- May serve as in-country Quality representative aligned with local regulations or laws (e.g. Mexico Sanitary responsible).
- Participates and hosts internal and external audits. May serve as liaison between local health authority and the business.
- Maintains a comprehensive audit readiness program to ensure internal and external quality compliance.
- Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs.
- Establish local and regional relationships with regulatory affairs, commercial, and logistics team.
- Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).
- Maintains quality oversight of any local required establishment licences, or QMS certifications.
- Maintains local supplier/vendor selection, qualification, and audits.
- Maintains process for kitting/repack/relabelling activities (if any)
- Maintains quality records and adherence to records retention policies and procedures.
- Maintains quality oversight of field service processes/procedures.
- Maintains quality training program with respect to quality system elements.
- Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.
- Assesses product quality issues and escalates to upper management through established processes.
- Ensures timely post-market surveillance & vigilance (Field Actions and Product Complaints) management
- Ensures timely and consistent escalation of events.
- Responsible for communicating business related issues or opportunities to next management level
- Supports departmental and franchise objectives, while adhering to the ASP core values, as well as local safety and environmental policy and procedures.
Skills and Requirements:
- Minimum of 6 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field.
- At least 3 years' experience in the Medical Device industry.
- Demonstrated knowledge of regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, and ISO 14971.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Volpe at +44 203 800 1292 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.