Quality Assurance Engineer

QA Engineer

Liposphere is hiring a QA Engineer

Liposphere develops innovative Class III implantable medical devices and is advancing towards global commercialization.

Position Overview

The QA Engineer is responsible for supporting the Quality Management System (QMS) and ensuring that products are manufactured, tested, released, and maintained in compliance with applicable quality and regulatory requirements.

The role involves close collaboration with Production, Engineering, R&D, Clinical, Supply Chain, and Regulatory Affairs teams and supports quality activities throughout the product lifecycle, from development through commercial manufacturing and post-market activities.

Key Responsibilities

Design Control & Product Development

• Review design documentation, including design inputs, design outputs, verification, validation, and design transfer deliverables.

• Ensure design control activities comply with applicable regulatory and quality requirements.

• Participate in design review meetings and provide quality oversight throughout product development.

• Collaborate with R&D, Engineering, and Clinical teams to ensure design documentation remains complete, accurate, and compliant.

Risk Management

• Serve as the Risk Management Team Leader in accordance with ISO 14971.

• Lead risk management activities throughout the product lifecycle, including development, production, and post-production phases.

• Maintain and update Risk Management Files (RMFs).

• Ensure risk management activities are integrated with complaints, post-market surveillance, CAPA, and change management processes.

• Facilitate risk assessments related to product improvements, quality events, and design changes.

Change Control & Regulatory Impact Assessment

• Lead the Change Control process and ensure timely assessment and implementation of changes.

• Perform quality assessments for:

• Design changes

• Manufacturing and process changes

• Supplier changes

• Material changes

• Labelling and IFU updates

• Collaborate with cross-functional teams to define required actions and ensure proper implementation of approved changes.

• Verify that design, risk management, validation, and regulatory documentation are updated as required.

Complaint Handling & Post-Market Activities

• Lead the complaint handling process, including investigation, documentation, trending, and closure activities.

• Conduct complaint evaluations and determine potential impact on product safety and performance.

• Support vigilance reporting and regulatory notifications as required.

• Participate in Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities.

• Ensure complaint and PMS data are incorporated into risk management and continuous improvement activities.

Quality Systems & Compliance

• Support maintenance and continuous improvement of the Quality Management System.

• Support internal audits, supplier audits, Notified Body audits, and regulatory inspections.

• Participate in Management Review preparation and reporting activities.

• Support CAPA, deviation, and nonconformity investigations and associated effectiveness evaluations.

Cross-Functional Support

• Collaborate with R&D, Clinical, Manufacturing, Engineering, and Regulatory Affairs teams to support product lifecycle activities.

• Support preparation of regulatory submissions and technical documentation updates.

• Maintain awareness of applicable standards and regulatory requirements impacting company products.

Requirements

• Bachelor’s in Engineering, Life Sciences, Chemistry, Materials Science, or a related field; MSc preferred.

• 2–5 years of QA experience in medical devices (Class III preferred).

• Familiarity with EU MDR 2017/745, ISO 13485, and ISO 14971.

• Strong analytical, problem-solving, and root cause skills.

• Excellent documentation, communication, and organisational abilities.

• Able to work collaboratively across functions.

• Fluent English (written and spoken) required.

Please send your CV to jobsqa@liposphere.onmicrosoft.com