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Form of workMy client is seeking a talented and adaptable Quality Manager to join the organisation to aid with overall product Quality across their portfolio. In this role, you will oversee our existing Quality Management Systems and adapt them as the operations expand. Your primary responsibility will be ensuring product quality and driving continuous improvement in their manufacturing processes.
This role involves customer audits, as well as overseeing supplier quality through audits and capability development. You will also validate products and processes and oversee Corrective and Preventive Action (CAPA) activities while reporting into the Director of Quality Assurance.
Additionally, you will contribute to various project activities, such as auditing development projects, coordinating Failure Mode and Effects Analysis (FMEA) activities, and assisting with manufacturing process development, verification testing, logistics, planning, and design-for-manufacture and assembly.
Quality Manager Responsibilities:
- Manage and refine the existing Quality Management Systems to accommodate growing operations
- Oversee the control and monitoring of product quality, meticulously tracking any issues and driving continuous improvement initiatives within our manufacturing processes
- Conduct in-person and virtual customer audits, and take ownership of supplier quality management through audits, gap analysis, and capability development
- Ensure the validation of products and processes and supervise Corrective and Preventive Action (CAPA) activities
- Demonstrate keen attention to detail and process adherence, balanced with flexibility and pragmatism
- Thrive as part of a small, dynamic team, displaying self-motivation and the ability to work independently when necessary
- Contribute to various project activities, such as auditing development projects, coordinating Failure Mode and Effects Analysis (FMEA) activities, and supporting manufacturing process development, verification testing, logistics, planning, and design-for-manufacture and assembly
Quality Manager Requirements:
- Bachelor's degree in a STEM discipline
- 6+ years' experience in Quality Management within medical device or biotechnology sectors
- Strong understanding of Quality Management Systems adhering to ISO 13485, ISO 14971, CFR Part 820 and further regulatory requirements
- Proven track record managing audits and supplier quality management
- Certified lead auditor
- Ability to validate products and processes and oversee CAPA activities effectively
- Excellent communication, interpersonal, and problem-solving skills
- Keen attention to detail and a commitment to process excellence
- Ability to thrive in a fast-paced, collaborative environment
- Flexibility and adaptability to changing priorities and business needs
If you are a motivated and experienced Quality Manager looking to contribute to a dynamic team in the medical device space, please apply with an up-to-date CV.
