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.
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