Quality & Regulatory Affairs Engineer
We are looking for an experienced Quality & Regulatory Affairs Engineer to develop and strengthen our clients quality and regulatory processes across our engineering, manufacturing and powder production activities.
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.
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.
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.
Qualifications & Experience Essential:
- Strong background in Quality and Regulatory Affairs within an engineering or
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.
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 ISO13485.
- Experience within complex equipment, advanced manufacturing, powder metallurgy or metal powder production.
Working Hours:
37.5 hour working week Holiday entitlement:
25 days (Plus, Bank holidays)
To hear more about this exciting opportunity, please apply through the link and we will call you to discuss the position in more detail
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