Quality Engineer

Terry Parris Associates; Hailsham; On-site; GBP 35,000 - 52,000; Full time

Benefits offered by this job

25 days holiday

Job summary

Terry Parris Associates seeks a Quality & Regulatory Affairs Engineer to strengthen quality and regulatory processes across engineering, manufacturing and powder production. You will extend the ISO 9001 framework and ensure regulatory compliance across the business, collaborating with Engineering, Manufacturing, Sales and senior management.

You will lead audits, manage non-conformances and drive continuous improvement using PDCA, while guiding documentation and CE/UKCA activities for aerospace,

Qualifications

• Strong background in Quality and Regulatory Affairs within engineering or manufacturing.
• Good working knowledge of ISO 9001.
• Lead Auditor qualification or 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.

Responsibilities

• Develop and maintain ISO 9001 QMS across the business.
• Maintain Known Consigner status with authorities.
• Plan and conduct internal audits; support external certification audits.
• Manage non-conformances, corrective actions and continuous improvements.
• Capture regulatory requirements during design and manufacture of large-scale systems.
• Provide guidance on regulations and directives (e.g., Machinery Regulation, LVD, EMC, PED, ATEX).
• Support quality documentation and CE/UKCA compliance.
• Identify additional quality and regulatory accreditations for aerospace, defence, medical sectors.
• Collect and analyse quality data with Manufacturing and Powder Production; identify trends.
• Champion PDCA-based continuous improvement.
• Present quality data to customers.

Skills

Quality & Regulatory Affairs

ISO 9001

Lead Auditor

Non-conformances & corrective actions

Engineering/manufacturing processes

Regulatory interpretation

Analytical & communication skills

Education

Engineering/technical qualification (Degree or HNC/HND)

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)