Quality Manager

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:

• Bachelors 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