At a Glance
- Tasks: Develop and enhance quality and regulatory processes in engineering and manufacturing.
- Company: Join a forward-thinking company focused on quality and innovation.
- Benefits: Enjoy 25 days holiday, competitive salary, and a supportive work environment.
- Other info: Dynamic role with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact by improving quality systems and compliance in exciting sectors.
- Qualifications: Experience in Quality and Regulatory Affairs, with strong analytical and communication skills.
The predicted salary is between 40500 - 49500 £ per year.
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.
Quality & Regulatory Engineer employer: Terry Parris Associates Ltd
Terry Parris Associates Ltd is an excellent employer, offering a supportive work culture that values precision and attention to detail. Employees benefit from ongoing training and development opportunities, ensuring they grow alongside the company while working in a safe and collaborative environment in Lower Dicker. With a focus on quality and innovation in ultra-high-vacuum applications, this role provides a meaningful opportunity to contribute to cutting-edge manufacturing processes.
Contact Details:
Terry Parris Associates Ltd Recruitment Team
