We are looking for a candidate to join the team at BeFC to lead and conduct functions for planning, coordinating, development, and management of comprehensive compliance, quality assurance, risk management, and records management throughout the organisation.
The post holder will be expected to perform staff managerial duties to fulfill the role
BeFC encourage and support the personal and professional development of our staff. Individual development needs will be identified through a regular review process
From time to time, the post holder may be asked to assist with Continuing Professional Development (CPD) activities. This will form part of a substantive role and no additional payment for these activities should be expected.
The ideal candidate is self-motivated and drives change across key areas of the organisation. The surrounding organisation is not rigidly defined, so it’s important to be able to navigate an unstructured environment to fulfill critical business initiatives.
1) Responsibility for the quality assurance and compliance duties and obligations of the organisation.
2) Implements the relevant quality management systems (QMSs) / quality management frameworks (QMFs) and manage a quality control laboratory.
3) Develops, reviews and recommends policies and practices to comply with all necessary and recommended regulations.
4) Monitors standards and coordinates all aspects of implementation against the selected QMSs /QMFs, managing selected ISO certifications.
5) Consolidates process documentation and promotes process consistency.
6) Oversees the development of a comprehensive records management program.
7) Provide customer resolution and customer audits management, assuring the maintenance of records to ensure that stakeholders have appropriate traceability.
8) Organises and conducts quality assurance audits of various programs in accordance with standards and protocols.
9) Champion and advocate for ingrained quality and compliance processes and enhance quality culture across the organisation.
10) Work with various teams within the organisation to implement GxP processes.
11) Evaluates existing policies and procedures to coordinate internal practices to ensure compliance.
12) Develop and deliver training programs on quality management and compliance to all relevant employees
13) Oversees operational quality, recording all events and non-conformities during production.
14) Prepares audit reports and plans for corrective and preventative actions.
15) Administer programs for measuring quality and compliance through pertinent metrics on key performance indicators (KPIs), and providing periodic reports to management;
Graduate with quality management and/or quality assurance background (Master’s degree or equivalent)
Minimum 3 years’ experience in a similar role
Strong knowledge of quality assurance and compliance frameworks (e.g., ISO 9001 and ISO 13485)
Familiar with standards, policies, procedures and legislation
Ability to develop strong relationships and drive collaboration
Efficient at developing methods for effectively measuring compliance against goals and requirements
Strong technical and project management capabilities
Experience in planning, monitoring and supervising relevant staff
Proficiency in preparing clear and concise reports, correspondence, and other written records
Meticulous, taking pride in the quality of their work
Organised and rigorous
Ability to coach and mentor
Impeccable interpersonal communication skills
Objective-oriented
Understanding of English language, both written and oral
Minimum 2 years’ experience in a management role
Experience following medical device development and commercialisation (e.g., through clinical trials).