Quality Manager

Quality and Regulatory Compliance Manager / Quality Manager

• Annual Salary: 50,000 - 55,000
• Location: Newtown, Powys
• Benefits package and a chance to develop your career within a rapidly growing business

We are seeking a Quality and Regulatory Compliance Manager ensure the maintenance of an accredited Quality Management System and to grow the businesses already exceptional reputation for quality and service.

This is a senior management role, reporting to the UK Managing Director, will provide cohesion in leading and developing our Quality, Health & Safety, and Regulatory Teams, assuring compliance and continuous improvement.

Benefits for the Quality Manager

• Opportunity to lead and develop a critical department within the company.
• Be part of a company that values continuous improvement and compliance.
• Engage in a role that offers variety and the chance to work on multi-disciplinary procedures.
• With an established reputation in their specialist field, the company is on a strong financial footing and is capitalising on this to grow into new markets
• The have a world class facility and production capability.
• This role attracts a benefits package that includes life assurance and
• You will have several reports across different disciplines and be able to shape the future culture and practices of the teams.

Required Skills & Qualifications for Quality Manager

• Proven management and development of an established team.
• Experience working to specialist quality standards, ideally ISO 13485.
• Experience supplying customers within regulatory critical environments.
• Utilisation of quality functions to drive sales and business reputation.
• Experience in a rapidly improving environment.
• Strong background in SQA, Root Cause Analysis, CAPA, and ensuring traceability, accountability, data, and process integrity.
• Familiarity with machine-led production to order.

Day-to-day of the role:

• Manage and develop direct reports within the Quality, Regulatory, and Health & Safety teams.
• Ensure the UK QMS meets all requirements of the business scope, as well as alignment with the corporate QMS.
• Monitor and interpret regulatory changes to assess their impact on the business.
• Oversee projects to implement quality and regulatory changes.
• Evaluate, identify, and remedy policies and procedures proactively.
• Contribute to assessments ensuring the integrity of policies and controls.
• Report on current, emerging, and thematic risks and issues at senior management level.
• Ensure organisational compliance with multidisciplinary procedures.
• Contribute to product reviews and new product creation to ensure product governance.
• Manage programs for measuring compliance and quality through key performance indicators.
• Represent the business during regulatory and client inspections/audits.
• Prepare site/operation personnel for audits and prepare summaries and reports.
• Coordinate the preparation of regulatory/client audit responses and corrective action commitments.
• Provide regulatory guidance with respect to data usage and ensure compliance with data protection legislation.

To apply for the Quality and Regulatory Compliance Manager position, please submit your CV a detailing your management achievements, experience in quality standards, and your approach to ensuring regulatory compliance.