Quality Manager, Medical Devices
Posted 05/04/2024 by Russell Taylor Group Ltd
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
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
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
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
- Type:
- Permanent
- Start Date:
- 23/01/2024
- Contract Length:
- N/A
- Contact Name:
- Login or register to view
- Job Reference:
- J923479
- Job ID:
- 221418917
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