Quality Systems Engineer

Optima UK Inc Ltd; Leyfields; On-site; GBP 35,000 - 40,000; Full time

Job summary

A leading manufacturing company in the UK seeks a Quality Systems Engineer to develop and maintain its Quality Management System. The ideal candidate will have experience in quality roles within manufacturing, strong knowledge of ISO standards, and skills in data analysis and problem-solving. This role offers a salary of £35k - £40k and a Monday to Friday work schedule.

Qualifications

• Proven experience in quality systems or quality assurance role within manufacturing.
• Strong knowledge of quality standards including ISO, GMP, FDA.
• Experience with quality tools: CAPA, FMEA, Root Cause Analysis.

Responsibilities

• Develop and maintain the company's Quality Management System (QMS).
• Lead audits and ensure compliance for third-party inspections.
• Analyze quality data to identify improvement areas.

Skills

Quality standards knowledge

Analytical skills

Problem-solving skills

Communication skills

Experience with CAPA

Education

Certification in quality management systems

Job description

Job Role: Quality Systems Engineer

Location: Staffordshire

Shift: Mon - Fri / Perm

Salary: £35k - £40k

As a Quality Systems Engineer, you will be responsible for developing, implementing, and maintaining quality systems and procedures in line with regulatory and industry standards. You will work closely with cross-functional teams to ensure that products and processes meet internal and external requirements, and drive continuous improvement initiatives across the production environment.

Job Role Responsibilities:

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with relevant standards (e.g., ISO 9001, ISO 13485, AS9100).
• Lead internal and external audits, ensuring compliance and preparing for third-party inspections.
• Analyze quality data and trends to identify areas for improvement and root causes of non-conformances.
• Collaborate with production and engineering teams to drive process improvements and corrective actions.
• Manage document control and ensure all quality documentation is current and compliant.
• Support the Head of Production in promoting a culture of quality and continuous improvement across the organization.
• Provide training and guidance on quality system requirements to relevant personnel.

The Candidate:

• Proven experience in a quality systems or quality assurance role within a manufacturing or production environment - precision environment
• Strong knowledge of quality standards and regulations such as ISO, GMP, FDA if applicable.
• Experience with quality tools and methodologies such as CAPA, FMEA, Root Cause Analysis
• Certification in quality management systems - desirable
• Excellent communication, analytical, and problem-solving skills.
• Ability to manage multiple priorities and work effectively across departments