Information:
Job Vacancy Details
Quality Manager
Medical Devices
Bedford
Permanent ⁄ £50000 - £55000
Updated April 29, 2012
The Quality manager has overall accountability for Quality and Compliance within the R &D function within an In-vitro Diagnostics Medical Device Company. The company complies to ISO 13485 and US FDA 21 CDR Part 820 as well as other worldwide regulatory and compliance standards.
This position reports to the Head of Quality and has key responsibilities for the following areas;
• Ensuring all R&D projects have the correct understanding and knowledge of the quality requirements necessary to deliver a compliant Design File and associated documentation.
• Leading, managing and mentoring a team of Compliance associates. This includes all people management activities around goal setting, personal development and regular appraisals of team members.
• Management of audits of each project ensuring that compliance risks are fully understood and communicated at each design stage review. These audits will be integrated into the R&D Programme delivery schedule.
• Identifying any discrepancies in project compliance and addressing them through appropriate channels and support the implementation of corrective actions alongside the R&D project teams.
• Oversight and timely completion of actions arising from Management Board meetings.
• Maintenance of the design control processes in line with updated regulatory compliance while retaining a focus on appropriateness and business need.
• Lead any department specific corrective, preventive or improvement projects.
Who we're looking for
To be considered for this exceptional role you will need to meet the following criteria
• Multiple years experience of ensuring and managing quality and compliance within a medical device environment and preferably within R&D.
• A good knowledge of compliance management of products that have undergone the full design control lifecycle under ISO 13485 and US FDA 21 CDR Part 820 as well as other worldwide regulatory and compliance standards.
• Have previous experience in identifying opportunities for improvement within an established design control process and implementing these improvements.
• Design control guidance across multiple projects ideally across multiple sites.
• Proven ability as an effective people manager with leadership abilities over a technically skilled team.
• Lead auditor accreditation would be an advantage
About our client
Our client is a joint venture with a excellent product portfolio and a promising portfolio of new products. Based in Bedford, this medical devices business offers an excellent base salary and excellent benefits for the Quality Manager role.
What's on offer
£50,000 - £55,000 plus benefits.
Michael Page Contact
For further info, apply or phone on 0113 388 9000.
Job Ref: 13216394
Your application will be sent to Richard Goodall.
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