Job Description

Overview

Emblation is seeking a dedicated and proactive Quality Engineer to support the continued growth of our ISO 13485-certified medical device manufacturing operations. This role is critical in ensuring our electronic devices and consumables meet the highest standards of quality, safety, and compliance across global markets.

The successful candidate will play a key role in maintaining and enhancing our Quality Management System (QMS), supporting manufacturing and supplier quality, and driving continuous improvement initiatives across the lifecycle of our medical devices. This is an exciting opportunity to contribute directly to patient safety, product reliability, and regulatory compliance as Emblation scales production and expands internationally.

Key Responsibilities

Support and maintain the company's ISO 13485 and FDA-compliant Quality Management System, including CAPA, Non-Conformance, Risk Management, and Document Control. Lead and collaborate on investigations into product or process issues, driving effective root cause analysis and timely implementation of corrective and preventive actions (CAPAs). Perform and support validation activities including IQ/OQ/PQ for equipment, processes, and test methods. Participate in internal audits and support external regulatory audits (e.g., notified body, FDA, MDSAP) through document preparation, evidence collection, and response management. Monitor and analyse quality performance data (e.g. DPPM, NC trends, first-pass yield) and deliver actionable insights to management through dashboards and reports. Contribute to Supplier Quality Assurance by assessing suppliers, managing SCARs, and supporting BOM lifecycle risk management. Work cross-functionally with Manufacturing, Regulatory, and R&D teams to ensure product quality during design transfer, change control, and production. Train and coach internal teams on quality system procedures, regulatory expectations, and right-first-time practices. Support continuous improvement projects aligned with lean, Six Sigma, or risk-based principles.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related technical field. 2+ years' experience in a Quality role within a medical device, electronic manufacturing, or related regulated industry. Working knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, or MDSAP standards. Experience in CAPA, risk management (ISO 14971), root cause analysis, and validation. Strong data analysis skills with proficiency in reporting and problem-solving tools (e.g. 5 Whys, FMEA, Pareto analysis). Excellent communication skills, with ability to influence at all levels of the organisation. Experience with QMS software (e.g., Q-Pulse) preferred. Familiarity with electronic component manufacturing, PCB assembly, or device testing an advantage.
Job Types: Full-time, Permanent

Pay: 30,000.00-40,000.00 per year

Benefits:

Company pension Cycle to work scheme Employee discount Flexitime Free parking On-site gym On-site parking
Work Location: In person