Join our client, a recognised leader in the precision engineering and medical device manufacturing industry. In this role, you will be part of a dynamic, forward-thinking team dedicated to delivering world-class quality, compliance, and innovation.
Reporting to: Quality Director
Job Purpose: To provide technical guidance, structure, and leadership for the Quality function, ensuring that the site meets and exceeds the business and quality plans.
Responsibilities:
- Ensure compliance of quality systems with the QSR and all current pertinent regulations. (e.g. FDA, ISO). Act as a management representative for the standards in place within the company.
- Promote the awareness of applicable regulatory requirements and quality management system requirements throughout the company to drive improvements to overall quality and compliance.
- Participation, co-ordination and maintenance of the internal audit process.
- Identifying and analysing non-conformances and related trends. Ensuring issues are highlighted and escalated to Senior Management for corrective and preventive action facilitating business improvement.
- Promote awareness of customer requirements within the company.
- Support the training management process.
- Lead the implementation of Quality improvement projects.
- Contribute to Lean initiatives within the Quality function and across broader business operations.
- Technical Leadership.
- Participate in the interpretation of Engineering drawings.
- Provide support to the measurement system analysis process.
- Provide support to the inspection process and participate in the review of inspection reports.
- Provide support with the preventive maintenance and calibration systems.
- Provide support to the scrap analysis process.
- Participate in ongoing problem solving and on corrective action teams.
- Review and approve CAPA actions in conjunction with Quality Systems.
- Utilise Minitab and other statistical tools to perform root cause analysis, process capability studies, and data-driven decision-making.
- Lead statistical analysis initiatives to identify trends, reduce variability, and improve product and process quality.
- Participate in producing daily management reports with a view to identifying and making recommendations on improvement opportunities.
Experience:
- Bachelor’s degree in a scientific discipline is an advantage.
- Advantage of having a minimum 5 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment.
- Must have experience in people leadership role (at least 3 to 5 years).
- Demonstrated knowledge of Quality Assurance.
- Excellent communication skills, including the ability to communicate to all levels of an organization.
- Excellent analytical and problem-solving skills.
- Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance.
- Strong leadership skills, including influencing and team development.
- Thorough knowledge of QSR and ISO quality system requirements.
- Lead Auditor certification.
- Solid experience in medical device operations with a strong background in QA along with excellent communications and people management.
Skills:
Regulatory & Quality Systems Expertise, Statistical & Analytical Skills, Quality Assurance Leadership in Medical Devices
