Quality & Regulatory Engineer

Quality &amp; Regulatory Affairs Engineer<br />Location: Hailsham<br />Salary: £38 - £50k DOE<br />We are looking for an experienced Quality &amp; Regulatory Affairs Engineer to develop and strengthen our clients quality and regulatory processes across our engineering, manufacturing and powder production activities.<br />A key focus of the role will be to build upon our existing limited-scope ISO 9001 certification, working towards extending the Quality Management System across the whole business.<br />The role will work closely with Engineering, Manufacturing, Sales and senior management to ensure quality and regulatory requirements are understood and incorporated into our processes and projects.<br />Key Responsibilities

• Develop and maintain the Company's ISO 9001 Quality Management System, working towards certification across the whole business.
• Maintain status as Known Consigner with the relevant authorities
• Plan and conduct internal audits and support external certification audits.
• Manage non-conformances, corrective actions and continuous improvement activities.
• Support Engineering with regulatory requirements capture during the design and manufacture of large-scale systems.
• Provide guidance on relevant regulations and directives, including:
• Machinery Regulation (EU) 2023/1230
• Low Voltage Directive
• EMC Directive
• Pressure Equipment Directive (PED)
• ATEX
• Support technical documentation and CE/UKCA compliance activities.
• Work with Sales to identify additional quality and regulatory accreditations required to support opportunities within aerospace, defence, medical and other regulated sectors.
• Work with Manufacturing and Powder Production to collect and analyse quality and production data, identify trends and develop improvement plans.
• Champion continuous improvement using the PDCA (Plan-Do-Check-Act) approach.
• Support powder composition analysis and present quality and technical data clearly to customers.<br />Qualifications &amp; Experience Essential:
• Strong background in Quality and Regulatory Affairs within an engineering or<br />manufacturing environment.
• Good working knowledge of ISO 9001.
• Lead Auditor qualification or relevant auditing experience.
• Experience of quality systems, non-conformances and corrective actions.
• Good understanding of engineering/manufacturing processes.
• Ability to interpret regulatory and technical requirements.
• Strong analytical and communication skills.<br />Desirable:
• Degree, HNC/HND or equivalent engineering/technical qualification.
• Experience with CE/UKCA, machinery safety, PED, ATEX, EMC or electrical compliance.
• Knowledge of aerospace, defence or medical quality requirements, including ISO 13485.
• Experience within complex equipment, advanced manufacturing, powder metallurgy or metal powder production.<br />Working Hours:<br />37.5 hour working week Holiday entitlement:<br />25 days (Plus, Bank holidays)<br />To hear more about this exciting opportunity, please apply through the link and we will call you to discuss the position in more detail