Graduate Production Quality Engineer

JOB DESCRIPTION

Job Title: Graduate Production Quality Engineer

Department: Operations Production

Location: Brownhills UK (on-site role requires on-site presence)

Reports To: Senior Production Controller

Hours: Full-time

Contract: Permanent

1. OVERVIEW

Xstrahl has manufacturing facilities in the UK and USA and operates globally through its international network of distributors. Xstrahl is a leading designer and manufacturer of Superficial and Orthovoltage Medical X-ray Systems used in the treatment of cancers and dermatological disorders as well as a pioneer in the development of advanced X-ray systems for pre-clinical radiation biology research.

The Production Quality Engineer is a new full-time graduate role in Xstrahls UK production team. The role creates and maintains the build manuals and work instructions for Xstrahls systems carries out system sign-off checks develops production jigs and test equipment and manages production quality paperwork non-conformance reports (NCRs) change requests (CRs) and production feedback reports (PFRs) so that production issues are recorded followed up and resolved.

Working alongside an experienced Production Project Engineer and spending regular time on the production floor the job holder learns how Xstrahls medical and research X-ray systems are built tested and commissioned and captures that knowledge so it is documented repeatable and shared across the team. It is an opportunity to build a strong technical foundation in a regulated medical device environment and to grow into wider manufacturing engineering responsibilities such as build handover and process validation.

2. ACCOUNTABILITIES & SCORECARD METRICS

Build Documentation:

Owns the build manuals and work instructions for Xstrahls systems capturing build knowledge so every system can be built consistently from documented instructions.

Work Instructions Proven

Tests each work instruction on the production floor before release so instructions reflect how systems are really built.

Medical / Life Science System Sign-Off

Carries out system sign-off activities including electrical and mechanical checks so every system leaves production verified and documented.

NCR CR PFR & CAPA Management

Owns the logging progress and close-out of NCRs CRs PFR & CAPAs so production issues are recorded followed up and resolved rather than lost.

3. MAIN DUTIES

Build Documentation & Work Instructions

(Working alongside the Production Project Engineer.)

Create and maintain build manuals for each Xstrahl system.

Write clear step-by-step work instructions for each build stage including photos and diagrams.

Capture build knowledge from experienced engineers so it is documented and shared across the team.

Test draft work instructions by having an engineer build from them and update them based on feedback.

Keep build documentation under document control in line with the Quality Management System.

Support documentation for new products transferring into Xstrahl production including SARRP.

Production Quality Paperwork

Log progress and close out NCRs CRs PFRs and CAPAs chasing actions with the relevant teams.

Prepare NCRs and CRs for review and sign-off by the appropriate approver.

Support root cause analysis on production issues alongside the engineers.

Track trends in production issues and highlight repeat problems.

System Sign-Off

Carry out Medical and Life Science system sign-off activities including electrical mechanical and physics checks once trained and signed off as competent.

Perform physics checks including dose output measurements and beam alignment checks.

Commissioning sign offs on Life Science cabinet systems ahead of shipment.

Complete and file the sign-off and test records for each system in line with the Quality Management System.

Time on the Production Floor

Spend one to two days a week in production building alongside the team more during the first months.

Build the system being documented that week to understand each build first-hand.

Complete radiation safety training and the local rules sign-off before starting floor work.

Process Improvement & Development

Design and produce production jigs and test equipment to improve the manufacturing process.

Train the production team on new and changed processes.

Support the validation of process changes before they are introduced.

Support the handover of new builds from R&D into production.

Contribute ideas to improve build quality efficiency and test processes.

Supplier Support

Support the onboarding of new suppliers from a manufacturing perspective.

Conduct supplier audits from a manufacturing perspective alongside the Purchasing & Logistics Manager.

4. KEY WORKING RELATIONSHIPS

Internal External

Operations Director (line manager)

Production Project Engineer

Senior Production Controller

Purchasing & Logistics Manager (supplier onboarding and audits)

Production Team Leader

Production Engineers

Quality / QARA team

Engineering / R&D (new builds and design changes)

Logistics & Operations Coordinator

Suppliers (onboarding audits drawing and specification queries)

External auditors (in support of QMS audits)

5. PERSON SPECIFICATION

Essential

A degree in mechanical electrical electronic manufacturing or a related engineering or science subject.

Clear written communication able to turn a technical process into simple step-by-step instructions.

Organised with good attention to detail and a careful approach to accurate records.

Practical and hands-on and keen to learn how systems are built.

Willing to take ownership and see tasks through to completion.

Comfortable using Microsoft Office.

Desirable

Any practical or workshop experience such as a placement internship university project or summer job.

Familiarity with reading engineering drawings or wiring diagrams.

Experience with CAD software or writing technical documentation.

Any hands-on experience with tools electrical testing or making things in a workshop.

An interest in medical devices or regulated industries.

Awareness of quality systems such as ISO 13485 (not required as full training is provided).

Key Competencies

Attention to detail and accuracy.

Clear technical writing.

Ownership and initiative.

Curiosity and willingness to learn.

Practical problem-solving.

No previous industry experience is required. Full training will be provided.