Quality Assurance Specialist

Arevna Limited; United Kingdom; Ibrido; GBP 69.000 - 83.000; Tempo pieno

Descrizione del lavoro

Arevna Limited is seeking a Quality Consultant (Medical Devices) to work on the UK production floor with manufacturing and engineering teams, driving defect reduction and root-cause investigations in real time. The role emphasizes on-site presence and pragmatic use of ISO 13485 and ISO 14971, with experience on DHF/Technical File maintenance and Notified Body readiness.

If you enjoy hands-on problem solving, you’ll partner with operators on the line to remediate issues at source and help ensure

Competenze

• Medical device background with solid knowledge of ISO 13485 and ISO 14971.
• Experience with structured investigation tools (8D, 5 Whys, Ishikawa, FMEA).
• Experience with DHF/Technical File maintenance or audit readiness (Notified Body / BSi).

Mansioni

• Be the operational quality partner to Manufacturing and Engineering, tackling defect reduction, yield consistency, and 8D/root-cause investigations on the line.
• Connect production reality back into ISO 14971 risk files and Technical File remediation (UK MDR / EU MDR).
• Promote a pragmatic ISO 13485 culture that minimizes bureaucracy.

Conoscenze

ISO 13485

ISO 14971

8D

5 Whys

Ishikawa

FMEA

DHF/Technical File

Descrizione del lavoro

Job Title: Quality Consultant (Medical Devices)

Location: UK (On-site manufacturing focus / Hybrid)

Hourly Rate: £50-60 per hour

Sector: MedTech / Healthcare Manufacturing

Most Quality roles keep you glued to a desk reviewing change requests all day. This isn't that.

If you are a quality engineer who actually likes being on the production floor diagnosing why a batch drifted, working with machine operators on root causes, and fixing systemic issues at the source this is built for you.

We are partnering with an expanding UK medical device manufacturer dedicated to complex patient care to appoint a Quality Specialist/Consultant.

What makes this mandate different:

• True Shop-Floor Presence: You will be the operational quality partner to Manufacturing and Engineering, tackling defect reduction, yield consistency, and 8D/root-cause investigations on the line.
• Closed-Loop Impact: You won't just log NCRs you will connect production reality back into ISO 14971 risk files and Technical File remediation (UK MDR / EU MDR).
• Pragmatic Culture: A team that uses ISO 13485 as a framework to build better products, not an excuse to create unnecessary bureaucracy.

What you bring:

• Medical device background with solid knowledge of ISO 13485 and ISO 14971.
• Practical mastery of structured investigation tools (8D, 5 Whys, Ishikawa, FMEA).
• Experience with DHF/Technical File maintenance or audit readiness (Notified Body / BSi).
• A pragmatic, approachable style that earns credibility with manufacturing teams.