Quality and Regulatory Compliance Manager / Quality Manager
- Annual Salary: 50000 - 55000
- Location: Newtown, Powys
- Benefits package and a chance to develop your career wihtin 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 specilist 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 futre 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.