Quality Engineer

ZipRecruiter; Maldon; On-site; GBP 40,000; Full time

Job summary

A leading manufacturer in the Essex area seeks a Quality Engineer to join their team. In this hands-on role, you will ensure quality assurance throughout the product lifecycle in a regulated environment. You will collaborate with internal teams and customers, define inspection criteria, and lead quality improvement initiatives. Ideal candidates should have experience in the medical device industry and strong knowledge of ISO standards. This is a full-time, on-site position only.

Qualifications

• Experience working in a regulated industry (medical device, pharmaceutical).
• Knowledge of ISO 9001, ISO 13485, MDD/MDR, CFR Part 820.
• Excellent communication and organisational skills.

Responsibilities

• Act as Quality Assurance liaison for internal teams and customers.
• Manage change control processes in line with quality requirements.
• Promote quality awareness across the business.

Skills

Quality Assurance liaison

Validation and verification

Inspection criteria definition

Technical Files maintenance

Problem-solving activities

Change control processes

Internal audits support

Quality training activities

Education

Qualification in engineering or technical discipline

Tools

Statistical analysis tools (e.g. Minitab)

Quality tools (FMEA, RCA, CAPA)

Job description

Job Description

Quality Engineer - Medical DevicesLocation: Southminster, EssexSalary: £40,000Job Type: Full-Time, On-Site

Are you passionate about quality and ready to take your next step in the medical device industry? A leading manufacturer is seeking a Quality Engineer to support the development and delivery of high-quality products across the full product lifecycle. This is a hands-on, full-time position based on-site at a modern facility in Essex - just a 2 minute walk from Southminster train station.

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

• Act as the Quality Assurance liaison for internal teams and customers

• Support validation and verification activities, both internal and customer-led

• Define in-process inspection criteria using process outputs

• Assist with the creation and maintenance of product Technical Files (CE/UKCA)

• Contribute to the improvement of internal processes and the Quality Management System

• Lead problem-solving activities (e.g. RCA, CAPA, 8D)

• Manage change control processes in line with quality requirements

• Support internal and supplier audits, ensuring corrective actions are implemented

• Promote quality awareness across the business and assist with training activities

What We're Looking For

• Experience working within a regulated industry (medical device, pharmaceutical, or similar)

• Qualification in an engineering or technical discipline

• Knowledge of standards such as ISO 9001, ISO 13485, MDD/MDR, CFR Part 820, ISO 14971

• Hands-on experience with quality tools and techniques (FMEA, RCA, CAPA, 5 Whys, APQP, etc.)

• Familiarity with Technical File and maintenance for CE/UKCA marking

• Excellent communication, time management, and organisational skills

• Proficiency in statistical analysis tools (e.g. Minitab)

• 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

SER-IN