Head of Quality & Regulatory based in Manchester. Senior Management role with a well established global manufacturing company.
Client Details
Our client is a global, well established manufacturing company that supplies bespoke, innovative products to a wide range of highly regulated and safety critical market sectors
Description
This Head of Quality and Regulatory role is a critical position within Group globally. It's a highly regulated industry, making quality and compliance the number one focus in everything our client does. Sitting within the category team, this individual is responsible for a team covering our manufacturing and external suppliers on all aspects of regulatory and quality. .
The role included but is not limited to:
1. QMS - Responsible for the development and ongoing maintenance of robust quality management systems ensuring the company's statutory and contractual duties are fulfilled and exceeded. Ensure systems and services are monitored and reviewed to continually improve quality standards.
2. Provides clear, constructive regulatory advice and guidance to the organisation and is responsible for the design and execution of all regulatory strategy
3. Support and represent the Quality & Regulatory discipline in new product introduction and product development projects to ensure all aspects of quality, testing and certification are undertaken correctly.
4. Oversight of internal and external compliance activities, ensure the organisation is compliant and prepared for audits
5. Undertake due diligence to validate and approve new suppliers and manage the ongoing requirement and audits
6. ISO - Maintaining current and creating new ISO documentation for each site and increasing scope of certification as necessary.
7. Manage the relationships with the key Certification Bodies (BSI, SATRA, SGS, INSPEC etc.) for the ISO Management System Audits, Product Testing and Certification
8. Responsible for the internal lab and ensuring the in-house compliance testing has been completed on an ongoing basis, to ensure product is still meeting the standard. Working closely with Production to ensure all manufactured product is compliant
9. Responsibility for all products coming out of UK manufacturing sites as well as products which are sourced.
10. Responsible for collating all data for technical files including ensuring clinical evaluations are processed, risk assessments completed as well as all other items.
11. Collating data for the management review for ISO13485
12. Involvement in customer complaints relating to non-conforming product and Ensuring customer complaints are dealt with in a timely manner and manage the corrective action process
13. Provide escalation, weekly updates and reports to their line manager and wider management as required
14. Takes personal responsibility for the notification and tracking of Regulatory and quality activities and related database entry/data accuracy.
15. Highlights any updates to regulatory requirements to senior management
16. Maintaining the calibration register for testing and measuring equipment
Profile
Qualifications: Degree or equivalent
Experience:
Experience of working in a manufacturing environment.- highly regulated or safety critical. Ideally sectors such as Medical Devices, pharmaceutical, aerospace, automotive, defence, healthcare or alike.
Experienced quality and regulatory professional with working knowledge of ISO9001 and MDD / MDR.
Experience of working with Class 1 and Class 2a (sterile) Medical devices
Internal audit qualification for ISO9001 (minimum)
Knowledge of other standards such as ISO14001, ISO45001 and ISO13485 would be an advantage. Experience working with European and International Standards
Behaviours:
This is not an advisory role. The post holder will be a self-starter who is eager to get stuck in with the team and make things happen.
They will be expected to manage their own time, prioritise their work and deliver to deadlines, taking full responsibility for their area of work.
This role will involve working with people across the organisation, in every department and with key stakeholders in the leadership team. The ability to collaborate, lead and support team members will be essential.
Job Offer
70,00 to 90,000 plus package
