Junior Quality Engineer - MedTech
Vollzeit
Michael Page
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.
- 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.
- 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.
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