Head of Quality, Safety, Health, Environment and Risk at Next Biosciences

We are seeking a highly motivated and experienced Head of Quality, Safety, Health, Environment and Risk to join our team. As a Head of QSHE and Risk, you will be responsible for Ensuring compliance with the Quality Management System of Next Biosciences. The maintenance of SAHPRA requirements for medical devices, ISO 13485 accreditation (Medical Device Quality Management Systems), AABB (American Association of Blood Banks) accreditation and the implementation if ISO 15189 (Medical Testing). Ensuring Compliance to Health and Safety Requirements.

Minimum requirements:

• Tertiary education-Certification in OSH&E, Risk management and Quality.
• Management experience (5 years)
• Quality Management Experience (5 Years and more)
• Internal Auditor experience in Medical QMS.
• Experience in Product registration and maintenance with SAHPRA.
• Previously worked in a laboratory.
• Computer literacy –word, excel and power point.

Skills required for the position:

• Careful and meticulous
• Ability to work as a team member and individually.
• Enthusiastic, motivated, and capable of prolonged concentration and attention to detail
• EQ Skills development
• Ability to Motivate team members and drive Objectives, goals and KPI to completion

Key Accountabilities:

• Assist and guide quality officer with the QMS.
• Ensuring that written procedures are consistent with each other.
• Scheduling and facilitating risk review and implementation of risk reduction.
• New Regulatory and Standards - Change control procedure implementation and checks.
• Trending of Quality Objectives as set out by EXCO.
• Internal audits to set quality standards (SAHPRA, ISO 13485, AABB, ISO 15189)
• Responding to customer complaints.
• Monitoring vigilance procedures.
• Facilitating implementation and understanding of the quality management system
• Updating the quality management system to reflect the objectives of the company and the standards being adhered to.
• Management Review reports and meetings
• Acting as QMR (Quality Management Representative) or company representative during audits or regulatory compliance meetings.
• Promoting the values of Next Biosciences as an integrated part of our written policies and procedures
• To adhere strictly to Next Biosciences Administrative Policies, Standard Operating Procedures and Quality Management System.
• To be responsible for the time management of multiple tasks and to respond to changing requirements by taking on additional tasks and responsibilities as required.
• To perform and organise their own work.
• To Report on all activities of the QMS.
• Compilation of Quarterly board reports.
• Conduct Internal Training for employees.
• Assist with Design and Development of new products.
• Ensure license applications and renewals are complete.
• Management of the Health and Safety Requirements as set out in relevant standards and local requirements.