Manufacturing Operations Quality Engineer R55936

As a Quality Engineer in Manufacturing, you will play a key role in ensuring that products are manufactured in compliance with internal quality standards, regulatory requirements, and our companys commitment to patient safety and product excellence. This position partners closely with Manufacturing, Operations, R&D, and Supply Chain to drive quality improvements and support continuous improvement initiatives on the production floor.
Responsibilities may include the following and other duties may be assigned:
Provide quality engineering support for manufacturing operations and engineering.
Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements.
Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
Collaborate with cross-functional teams to identify, assess, and mitigate quality risks in manufacturing processes.
Support internal and external audits, including preparation, participation, and follow-up on audit findings.
Drive continuous improvement initiatives using quality and lean methodologies.
Ensure effective implementation and monitoring of process controls and quality metrics.
Support change management activities ensuring requirements are identified and executed when applicable.
Participate in Management Review and Quality Metrics reporting.