Junior Quality Assurance Associate (Medical Devices)

Join Our Team at Glyance – QA Associate (Medical Devices)

Are you a detail-oriented Quality Assurance (QA) professional looking for your next challenge in the medical aesthetics industry? Glyance, a leader in innovative dermal fillers, is seeking a Junior QA Associate to join our team.

About the Role

As a QA Associate, you will play a key role in ensuring compliance with regulatory and quality standards for our medical devices. Reporting to the Head of QA, you will support the implementation, monitoring, and improvement of our Quality Management System (QMS) in accordance with ISO 13485 and EU MDR regulations.

Key Responsibilities

• Support QMS maintenance, audits, and regulatory compliance (ISO 13485, EU MDR, GMP).
• Assist in CAPAs, non-conformities, supplier approvals, and batch release.
• Conduct QA documentation reviews (SOPs, validation protocols, QC test support).
• Risk Management (ISO 14971): Participate in risk assessments and mitigation strategies.
• QC Support: Assist in quality control activities, including test verification and compliance.
• Validation & Qualification: Support process validation, equipment (IQ/OQ/PQ), and software validation.
• Sterilization & Packaging Control: Verify compliance with sterility validation and packaging integrity.
• Environmental & Cleanroom Monitoring: Ensure controlled environments meet quality standards.
• Support change control processes and QA training initiatives.

Qualifications & Requirements

• 2-3 years of QA experience in medical devices or pharmaceuticals.
• Knowledge of ISO 13485, GMP, and EU MDR (experience with CAPAs, batch release, or supplier audits is an advantage).
• Strong English proficiency (spoken and written).
• Detail-oriented, problem solver, and team player.

What We Offer

• Work in a fast-growing, innovative medical aesthetics company.
• Hands-on experience in medical device quality assurance.
• Collaborative team environment with industry experts.