Quality Engineer

TieTalent; Southminster; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading quality engineering firm in Southminster is seeking a Quality Engineer to ensure quality assurance across product development. The ideal candidate will have experience in regulated industries and knowledge of ISO standards. This full-time, on-site role demands strong communication skills and proficiency in quality tools. Candidates will work directly with cross-functional teams to support the Quality Management System.

Qualifications

• Experience working within a regulated industry (medical device, pharmaceutical, etc.).
• Familiarity with Technical File generation and maintenance for CE/UKCA marking.
• Lean Six Sigma experience is desirable.

Responsibilities

• Act as the Quality Assurance liaison for internal teams and customers.
• Support validation and verification activities.
• Lead problem-solving activities (e.g., RCA, CAPA, 8D).
• Manage change control processes.

Skills

Experience in a regulated industry

Excellent communication skills

Knowledge of ISO standards

Hands-on experience with quality tools

Statistical analysis proficiency

Education

Qualification in an engineering or technical discipline

Tools

Minitab

Job description

About

Quality Engineer - Medical Devices

Location: Southminster, Essex

Salary: £40,000+ (Apply online only)

Job Type: Full-Time, On-Site

About the Role

Reporting to the Quality Manager, you'll work closely with cross-functional teams to ensure quality is embedded at every stage of the process - from concept to production. You'll also act as a key point of contact for both internal teams and customers regarding quality assurance for a specific portfolio of products.

Key Responsibilities

1. Act as the Quality Assurance liaison for internal teams and customers
2. Support validation and verification activities, both internal and customer-led
3. Define in-process inspection criteria using process outputs
4. Assist with the creation and maintenance of product Technical Files (CE/UKCA)
5. Contribute to the improvement of internal processes and the Quality Management System
6. Lead problem-solving activities (e.g., RCA, CAPA, 8D)
7. Manage change control processes in line with quality requirements
8. Support internal and supplier audits, ensuring corrective actions are implemented
9. Promote quality awareness across the business and assist with training activities

What We're Looking For

1. Experience working within a regulated industry (medical device, pharmaceutical, or similar)
2. Qualification in an engineering or technical discipline
3. Knowledge of standards such as ISO 9001, ISO 13485, MDD/MDR, CFR Part 820, ISO 14971
4. Hands-on experience with quality tools and techniques (FMEA, RCA, CAPA, 5 Whys, APQP, etc.)
5. Familiarity with Technical File generation and maintenance for CE/UKCA marking
6. Excellent communication, time management, and organisational skills
7. Proficiency in statistical analysis tools (e.g., Minitab)
8. Lean Six Sigma experience is desirable

Working Conditions

• Occasional work in a cleanroom environment with full PPE required
• On-site role only - this position is not suitable for remote or hybrid working

Location

Southminster, England, United Kingdom

Work Experience

QA

Languages

English