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Job Title: Quality Manager
Are you working with the medical industry at the moment and looking for a step up or just looking for a new opportunity as a Quality Manager?
One of my clients who specialise in medical devices, have an opportunity to be a part of their exciting company. Your role would include to plan, organise, lead and monitor quality management activities throughout the business, support stakeholders, ensuring systems and controls are implemented to maintain safety of the products.
Key Responsibilities of the role:
• To ensure that there is a QMS in place that satisfies the requirements of the relevant quality standards
• To strategically create and implement the QMS Audit Plan
• To implement improvements where necessary in collaboration with relevant stakeholders,
• Implementation of QMS Audit against Audit Plan to assure adequacy of the QMS
• Communication of issues from audit, and escalations as necessary.
• Identification of action priorities based on Gap Analysis from Internal Audit.
• Documentation of action items, and resolution plans.
• To train and mentor employees in the effective use of the QMS tools.
• To provide quality assurance support of design and development process throughout the product development lifecycle for:
• Extensive experience working in product development and delivery
• Experience in working with PEMS (Programmable Electrical Medical Systems)
• Experience and capability in root cause analysis, leading issue investigation and resolution, documentation and testing
• Familiarity with regulatory standards i.e. MDD (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820, 21 CFR 807, 21 CFR 11
• Ability to lead; demonstrating assertiveness, team building and management skills
If this role sounds like something of interest then send a copy of your CV to email@example.com
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