Quality Manager Medical Devices

QUALITY MANAGER – MEDICAL DEVICES Attractive Basic & Benefits Northwest Based THE COMPANY Part of a dynamic European e500m consumer healthcare and homecare group, this UK-based autonomous division markets a broad range of multi-category personal care, beauty cosmetics, and medical healthcare brands and own label products. The business has grown substantially and is now looking to further invest in their management team with the appointment of a Quality Manager – Medical Devices to manage their range of both brand and own label medical products. My client has a hard-working, friendly team culture who are supported and motivated to achieve their collective business growth objectives and individually ‘do a great job’. THE ROLE Reporting to the Head of Technical, this role will: Directly manage and have full hands-on control of all aspects of product quality management associated with the designated product portfolio involving working with key suppliers/agencies and major retail customers. Manage all existing and new product launches to ensure compliance with UK and EU regulatory standards, together with accurate maintenance of the QMS system for the medical device portfolio. Control all Quality system processes for the range of medical device products to ensure compliance with legislative/regulatory and customer guidelines and take action to amend/update with appropriate internal and external timely communications. Work cross-functionally with all internal and external stakeholders including NPD, assisting with the creation of artwork and packaging and all quality documentation ensuring compliance to ISO 13485, 14971 & 15223 etc. for effective trade product launches. Manage product complaints as required with consumers and trade customers to ensure effective resolution while maintaining high customer service standards. ABOUT YOU You will have a minimum of 3 years’ experience working in a medical product manufacturer or major retailer. You are currently working at Quality Assurance specialist/technician or officer capacity level and looking for a career development move into a Quality Manager position. Alternatively, you could already be a Quality Manager looking for a fresh career challenge. You have gained experience and a proven track record of implementing and maintaining a quality management system including ISO 13485. You are competent in managing packaging artwork creation and reviewing detail in accordance with ISO 15223. You are outgoing, personable and love working as part of a team that consistently drives to achieve the highest standards working cross-functionally with all key stakeholders both internally and externally. You have working knowledge or experience of IVD/IVDR and the ability to act as the PRRC for medical device products would be of benefit to this appointment. If this sounds like the career opportunity you are looking for, please apply to Mark at smithcarey.co.uk quoting reference number

MS/2495

and attach your CV together with salary details OR give Mark a call for a confidential initial discussion on 07747 847214. Closing date for applications: 24th December 2024.

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