Quality Manager, Medical Devices

Quality Manager, Medical Devices
Location: North Yorkshire - x2 days a week hybrid option/ remote
Type: Permanent
Salary: £75000
Benefits include: 6.6 weeks holiday including BH, onsite gym & canteen, private healthcare insurance, dental plan, discounted high street shop vouchers, free parking, bonus scheme (upto 15%)
Hours of work: Monday - Thurs 8-16.30, early finish on a Friday (13.00)
Flexible working, can start the day at 7am and finish at 3.30pm, or 9am and finish at 5.30pm
Russell Taylor Group is working exclusively with a global Medical Devices company based in North Yorkshire; the successful candidate will be responsible for management of the existing quality team/s and QMS implementation as well as adherence.
The role:-
Leadership of the Quality and Regulatory functions from a people, compliance and execution perspective. Develop and maintain a collaborative working relationship with the Global Quality & Regulatory Manager and other Site Quality Managers / Quality & Regulatory personnel within the Healthcare and Wellness Business Unit, supporting and implementing global strategic imperatives. Develop, maintain and promote a collaborative working relationship between the Quality & Regulatory function and appropriate stakeholders throughout the business. Drive and maintain Quality and Regulatory excellence with respect to people, design, quality, operations and compliance.
• Provide strong leadership of the site's Quality and Regulatory functional areas
• Member of the sites Leadership Team defining, implementing and supporting required growth and improvement projects
• Effective communication with internal and external functions including Operations, Supply Chain, Finance, Health & Safety, Human Resources, Technical & Scientific Services, Commercial and external partners
• Manage and maintain the Quality Management System to ensure on-going compliance of the Quality System to the following regulations: EN ISO 13485:2016, the FDA Code of Federal Regulations, 21 CFR Part 820 QSR, Medical Device Regulations, country specific regulations as required and those of customers as requested
• Compliance of the facility's Risk Management Files in accordance with ISO 14971
• Drive changes in procedures and standards to simplify and standardize to improve work efficiency whilst maintaining Quality and Compliance standards
• Hosting of external audits (Regulatory and customer)
• Execution of internal audits, as required
• Actively work with Project Teams to identify QMS and Regulatory requirements
• Maintain and update efficient site Quality metrics feeding into Management Review
• Consistently promoting awareness of best industry practices and making appropriate decisions on a daily basis
• Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality and Regulatory Management System on-site
• Manage site compliance with all UK Manufacturing Regulations as applicable, such as REACH, GDPR and MDR
• Setting goals and objectives for the Quality and Regulatory functions, ensuring alignment with strategic imperatives and key customers
• Ensure clear strategies are in-place to develop the roles within each Quality and Regulatory functional area and the individuals within them
The person:
• Will hold an Degree in a STEM related subject
• Significant experience working in an QM role within an ISO 13485 setting is essential
• Lead auditor qualification preferred
• Experience in auditing hosting
• Previous leadership experience within in QM setting would be preferred
• Experience in risk file management
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