Quality & Regulatory Engineer

Terry Parris Associates Ltd; Hailsham; On-site; GBP 50,000 - 70,000; Full time

Job summary

Terry Parris Associates Ltd in the United Kingdom is seeking an experienced Quality & Regulatory Affairs Engineer to strengthen our quality and regulatory processes across engineering, manufacturing and powder production. You will build on ISO 9001 capabilities and extend the QMS across the business.

You will collaborate with Engineering, Manufacturing, Sales and senior management to ensure compliance with international and UK regulations, support audits, and drive continuous improvement using

Qualifications

• Strong background in Quality and Regulatory Affairs within an engineering/manufacturing environment.
• Good working knowledge of ISO 9001.
• Lead Auditor qualification or auditing experience.
• Experience with 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 Quality Management System across the business.
• Maintain status as Known Consigner with authorities.
• Plan and conduct internal audits and support external audits.
• Manage non-conformances, corrective actions and continuous improvement.
• Support regulatory requirements capture during design and manufacture of large-scale systems.
• Provide guidance on regulations and directives, including: Machinery Regulation (EU) 2023/1230 Low Voltage Directive EMC Directive PED ATEX CE/UKCA compliance activities.
• Work with Sales to identify additional quality and regulatory accreditations for 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.

Skills

Quality management

Regulatory affairs

Auditing

Analytical skills

Communication skills

Education

Engineering degree or equivalent

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 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)