This exciting opportunity is for an innovative, critical thinker who has strong knowledge of quality principles and the ability to apply these methods in a manufacturing. It will also require a leader who will take responsibility in developing and implementing new techniques and initiatives to enhance the quality management system on the site and across the corporation where possible.
This role is for a quality leader who is looking for a role where their skills and experience will be utilised to make positive changes in the business.
- Ensures the processes needed for the Quality Management system are established, implemented and maintained.
- Compile and analyse operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- Take a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where possible.
- Develop, implement and monitor annual Quality Objectives for the department & the wider Quality organisation as required.
- Ensure compliance with safety, regulations, ISO standards, Quality Business Systems and Corporate Policies.
- Control budgets and spending and ensure compliance to financial requirements.
- Project manage and schedule key projects and initiatives ensuring timely execution and goal achievement.
- Integrate with corporate requirements and promotes synergy/consistency with other sites and corporate.
- Assist Managing Director/ Site Operations Manager in developing strategies for the quality function.
- Acts as the champion for the customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization.
- Promotes awareness of regulatory and customer requirements throughout the organization.
- Presents all aspects of CM’s quality policies and standards to customer/ potential customers while building professional rapport and relationship with them.
- Build external relationships; improve the company’s knowledge of regulatory trends and position company to efficiently comply to standards including vendors, service providers etc
- Develop regulatory strategies and provide strategic regulatory input and support throughout the organisation. Convert strategies to established business practices throughout the organisation.
- Build internal relationships; improve knowledge of business and relative departments ensuring that quality and compliance is the highest priority.
- Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
- Be recognised as leader of behavioural/GMP and cultural initiatives with strong quality related decision-making skills demonstrated.
- Level 8 degree (minimum) in a relevant Engineering/Science discipline
- Experience in Medical Device environment
- 3 years + experience (minimum) in a leadership role within a manufacturing environment
- Experience/training in problem solving and process improvement methodologies
- Excellent analytical and problem-solving skills
- Strong knowledge of quality principles and the ability to apply these methods in a manufacturing