Engr , Quality
Listed on 2026-07-01
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Engineering
Quality Engineering, Regulatory Compliance Specialist
Quality Engineer II
Provide Quality Engineering representation on various project teams supporting product remediation. Initiate new or revised documentation. Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies. Lead cross-functional teams to develop risk assessment. Develop physical and functional test methods to ensure specifications are met. Write, review and approve design verification and validation protocols and reports.
Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications. Conduct and/or coordinate testing outlined in protocols and test methods. Perform process improvement, control and monitoring on manufacturing processes. Provide technical direction during design transfer activities. Participate and provides input to training on department/division procedures, and policies. Develop and implement procedures to comply with corporate and industry standards. Understand and follow company procedures on regulatory requirements.
Provide support to the regulatory department in writing technical submissions. Provide positive example and actively promotes compliance to all standards. Maintain a professional working relationship with internal and external customer and support staff. Prepare and present project updates and technical discussions. Familiar with the latest editions of standards IEC 60601 Series (especially 60601-1 and 60601-1-2), IEC 62304, IEC 62366 & ISO 14971.
Familiar with sampling standards like ANSI/ASQ Z1.4, ISO 2859-1 and ANSI/ASQ Z1.
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