Quality and Regulatory Affairs Manager

Quality and Regulatory Affairs Manager

Job Type:  Full Time

Location: Huntingdon

Salary: Competitive depending on experience

A supplier of high-quality metals and materials, the company specialises in the research and development sectors with a strong focus on science and industry. Their technical teams have worked on materials that have contributed to scientific breakthroughs in nuclear fusion, the fight against COVID-19, and have been used in probes that have travelled through space as far as Saturn.

The Role

The team are primarily responsible for ensuring that the business adheres to external rules and regulations and internal controls. The team also enables the business to navigate through complex regulations and unlock opportunities by applying their knowledge and offering their guidance with respect to international trade, products, and other regulatory areas. Although small, the Compliance team works with all departments and performs an essential function within the evolving business.

The Quality and Regulatory Affairs Manager will be a key member of this team, ensuring the QMS is fit for purpose and utilised effectively. The company are IOS9001 accredited and work closely with highly regulated industries including Aerospace and Medical. Regulation changes and increasing requirements from Aerospace and Medical customers require a level of expertise beyond their current ISO 9001 position.

• Develop, manage, and maintain the Quality Management System (encompassing areas of Quality, Regulatory and Environment).  Current ISO9001 compliant QMS to be developed to meet future requirements.
• Develop and manage change control procedures.
• Identify, lead, and manage Quality System improvements.
• Undertake regular internal and process audits of the QMS.
• Manage the audit program to ensure that all nonconformities raised from internal audits,
• certification bodies, customers or against suppliers are route cause corrected and independently
• verified.
• Host certification and surveillance assessments by external bodies and customers. Manage all
• external registration requirements to ensure they are met. Liaise with external bodies on all
• matters relating to registration. Maintain and improve, in line with business needs, including
• management of any non-conformities to completion.
• Support supply chain functions in supplier development activities.
• Coordinate responses to customers in relation to supply agreements, compliance questionnaires,
• and Regulatory requirements.
• Oversee provision and calibration requirements for inspection equipment.
• Produce, monitor, and evaluate effectiveness of Quality System KPIs.
• Champion Environmental Agenda recommending activity to help on the journey to Net Zero. 
• Manage and develop Environmental processes and procedures.
• Coordinate responses to customer questionnaires and quality agreements.
• Update and maintain Compliance and Risk Registers.
• Evaluate other standards which may enhance their reputation & capabilities, identify gaps,
• and develop steps required to achieve them.

Skills &Qualifications

• Demonstrable experience of managing and developing a QMS to meet ISO9001 requirements.
• Demonstrable experience of managing Medical (ISO13485) and/or Aerospace regulatory requirements. Experience of the implementation of either would be an advantage.
• Experience of Environmental systems management – working at ISO14001 level.
• Experience of working with the full supply chain in a materials or engineering business would be an advantage but not essential.
• Problem solving / analytical mindset.
• Demonstrable ability to influence across all business functions and comfortable with being customer facing.
• Self-motivating, persistent and tenacious.

Benefits

• Company healthcare.
• Company pension (5% company contribution).
• Company sick pay.
• 25-day annual leave.
• Free car parking.

To Apply

If you feel you are a suitable candidate and would like to work for this reputable company, please do not hesitate to apply.