Quality & Regulatory Engineer

Terry Parris Associates; Hailsham; On-site; GBP 55,000 - 75,000; Full time

Job summary

Terry Parris Associates is seeking a Quality & Regulatory Affairs Engineer to strengthen our quality and regulatory processes across engineering, manufacturing and powder production activities. The role focuses on expanding ISO 9001 certification and integrating regulatory requirements into design, production and supplier management, with close collaboration to engineering, sales and senior management.

You will lead audits, guide compliance activities and help develop documented processes to

Qualifications

• ISO 9001 knowledge and experience
• Lead Auditor qualification or auditing experience
• Experience with quality systems, non-conformances and corrective actions
• Ability to interpret regulatory and technical requirements

Responsibilities

• Develop and maintain the ISO 9001 Quality Management System across the business
• Maintain Known Consignor status with authorities
• Plan and conduct internal audits and support external certification audits
• Manage non-conformances and corrective actions
• Support regulatory requirements capture during design and manufacture
• Provide guidance on regulations and directives (Machinery Regulation, LVD, EMC, PED, ATEX)
• Support CE/UKCA documentation and compliance activities
• Identify additional quality/regulatory accreditations for aerospace, defence, medical sectors
• Analyze quality data with Manufacturing and Powder Production to identify trends and improvements
• Champion PDCA-based continuous improvement
• Present quality data clearly to customers

Skills

Quality management

Regulatory affairs

Auditing

Analytical skills

Communication skills

Education

Degree, HNC/HND or equivalent engineering/technical qualification

Tools

ISO 9001 knowledge

Job description

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 ISO 13485.
• 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)