Senior Quality Engineer
Work Flexibility: Onsite
The Quality Engineer will collaborate cross-functionally to resolve quality issues, drive continuous improvement, and ensure adherence to the Quality Management System and regulatory standards. Beyond quality, your efforts contribute to the organization's compliance with an array of other pertinent regulatory requirements that pertain to our industry and the markets we serve. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access.
- Support internal and external audit activities and address audit observations.
- Escalate quality issues to QA and/or Engineering Management and support timely resolution.
- Partner cross-functionally with Engineering, Production, and other teams to ensure quality standards are consistently met.
- Lead and participate in investigations of non-conformances, including risk assessments and corrective action strategies (CAPA).
- Ensure proper containment of non-conforming product (identification, segregation, and reconciliation).
- Monitor, analyze, and trend quality data to identify potential risks and provide insights to management.
- Ensure compliance with the Quality Management System and applicable regulatory requirements.
- Apply statistical and risk management tools (e.g., FMEA) to support decision-making and continuous improvement.
What you need:
- Bachelor’s degree in Engineering or a related technical field.
- Three years of experience in Quality Engineering.
- Strong working knowledge of 21 CFR 820, ISO 13485, and MDSAP.
- Advanced English proficiency (written and verbal).
