Engineer Sr., Quality - CR (Shift B)

Support the development and manufacturing of existing and new introduction of medical devices. Work with Manufacturing and R&D to resolve product quality issues which may include field complaints. Support manufacturing process changes, product design improvements, and the implementation of new products or hazards communications, exposure assessments, and waste management. Job duties:

• Work with manufacturing engineers to review process changes, resolve product quality issues, and assess related risks.
• Lead and support all transfers activities related with quality.
• Lead and/or support process, product, and/or equipment validation activities (IQ, OQ, PQ). Execute equipment validation activities as required.
• Obtain, analyze, and present to management the key performance indicators related to quality process.
• Work with R&D engineers to support implementation of new products by reviewing quality and testing plan and develop FMEAs.
• As assigned, maintain various Quality Systems such as CAPA, complaints, Non-conformance, supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.