Quality Engineer

Job Summary We are seeking a Quality Engineer to support laboratory quality and validation activities within a regulated medical device environment. This role is part of a global compliance team and focuses on ensuring adherence to quality standards through audit support, CAPA management, and nonconformance investigations. The ideal candidate will collaborate with cross-functional teams and contribute to maintaining high-quality performance and regulatory compliance. Key Responsibilities Support execution of quality systems for assigned laboratory teams, including tracking metrics such as nonconformance (NC), CAPA, and audit timelines Manage and support nonconformances, CAPA activities, and audit observations, ensuring timely resolution Review and support validation documentation including test methods, software validation, and instrument validation Review and approve calibration and maintenance records with oversight Support software validation activities for laboratory systems and tools Participate in Agile ceremonies such as scrum meetings and collaborate with global teams Act as a point of contact for compliance-related issues Compile and track nonconformance records and related quality documentation Work closely with Test Engineers, R D, and Quality teams to ensure compliance and quality deliverables Required Qualifications Bachelor's degree in Engineering, Science, IT, or a related field Minimum 2 years of experience in a regulated industry Experience working with quality systems and processes Experience handling nonconformances (NCs) and CAPA processes Experience with software validation and laboratory environments Strong technical writing, analytical, and problem-solving skills Ability to manage multiple tasks and priorities effectively Strong attention to detail and documentation skills Preferred Qualifications Experience in a medical device laboratory environment Knowledge of regulatory guidelines and compliance standards Experience with ETQ or similar quality management systems Experience in design or product/process quality engineering Familiarity with laboratory testing environments and validation processes