|Job Title:||Quality Manager|
|Location:||Birmingham, West Midlands|
|Contact Name:||Rachel Radford|
|Job Published:||February 08, 2017 15:23|
Key responsibilities include but are not limited to:
- To ensure that there is a QMS in place that satisfies the requirements of the relevant quality standards (including but not limited to ISO13485 and 21CFR820) ensuring that it matches business needs and satisfies the requirements of all target markets.
- To ensure that tools are in place to support effective work processes and conformance to the QMS.
- To provide quality assurance support of design and development process, driving adherence to and efficiency of company procedures throughout the product development lifecycle for:
- Setup of Quality Plan for products
- Definition of Supplier Audit Plan, based on business priorities
- Implementation of Supplier Audit against Audit Plan to assure adequacy of the Product Supply Chain, and reporting to Senior Leadership on conformance and effectiveness of the Supply Chain based on Audit findings
- To define and implement an integrated issues management process with documented workflow, covering:
- Complaints / Adverse Events handling
- Engineering Issues Management
- Audit non-conformity handling
- Engineering Change
- Management of Document Administration Process
- To ensure that a comprehensive set of KPI's are defined, to measure performance of the company against agreed targets.
- To mentor direct reports, ensuring that there is a common agreement on strategy, priorities and deadlines and to maintain a strong understanding of delivery against plans and targets.
- Extensive experience working in product development and delivery
- Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multi-disciplinary development effort (mechanical, software, electronics, system integration, pneumatics, fluid mechanics etc.)
- Experience and capability in root cause analysis, leading issue investigation and resolution, documentation and testing
- Experience of working with requirements management systems, document management systems and issue management systems
- Experience in definition and qualification of tools in support of the QMS
- 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
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