Junior Quality Engineer - MedTech

• ISO 13485 required
• Startup environment

About Our Client

Our client is an innovative medical technology company focused on developing advanced healthcare solutions that improve patients' quality of life. Operating in a highly regulated environment, the company combines scientific excellence, operational rigor, and a culture of collaboration and continuous improvement.

Job Description

• Review and approve manufacturing batch records while ensuring adherence to quality and regulatory requirements.
• Support incoming inspection activities, including review of certificates, inspection reports, and material documentation.
• Participate in non-conformance investigations, root cause analysis, and CAPA implementation.
• Support equipment qualification and process validation activities (IQ/OQ/PQ) at supplier and manufacturing sites.
• Ensure quality compliance throughout the product lifecycle in collaboration with external suppliers and manufacturing partners.
• Contribute to product release activities through quality record reviews and verification of test results.
• Collaborate closely with Regulatory Affairs, Procurement, Manufacturing, and Quality teams.
• Participate in supplier audits, readiness assessments, and continuous improvement initiatives.
• Maintain compliance with ISO 13485, FDA requirements, MDR, and internal quality management systems.

The Successful Applicant

• Bachelor or Master's degree in Engineering, Life Sciences, or a related technical field.
• 3-5 years of experience in Quality Operations within the medical device or another regulated industry.
• Knowledge of ISO 13485, FDA Quality System Regulations, and GxP requirements.
• Experience working with suppliers and contract manufacturing organizations.
• Familiarity with NC, CAPA, batch record review, validation activities, and risk management methodologies.
• Strong analytical, communication, and problem-solving skills.
• Experience with electronic quality management systems is considered an asset.

What's on Offer

• Opportunity to join a growing and innovativeMedTechorganization.
• Exposure to a broad range of Quality Operations activities and international stakeholders.
• A collaborative environment focused on innovation, quality, and continuous improvement.
• Competitive compensation package and strong career development opportunities.