Work Flexibility: Onsite As a Quality Engineer, you will support Quality Assurance activities within a regulated medical device environment, partnering with Manufacturing, Research & Development, Regulatory, and Engineering teams. You will monitor product and process quality, investigate nonconformances, manage quality data, and support compliance with FDA Quality System requirements, ISO 13485, and the Medical Device Single Audit Program (MDSAP). What you will do •Investigate product and process quality issues with cross-functional teams, performing risk assessments, historical record reviews, nonconformance evaluations, and corrective action activities. •Coordinate containment and disposition of nonconforming product, including identification, segregation, reconciliation, and documented resolution. •Monitor and trend quality data to identify potential issues and provide data-based quality insights to management. •Manage Corrective and Preventive Action (CAPA) activities and verify compliance with Quality Management System requirements. •Apply statistical methods to establish sampling plans and evaluate the effectiveness of corrective actions. •Interpret risk management documentation, including Failure Modes and Effects Analysis (FMEA), to support quality and risk-based decisions. •Support internal and external audits, respond to audit findings, and evaluate Quality Management System changes required to maintain regulatory compliance. •Partner with Quality Assurance, Manufacturing, Engineering, Research & Development, and Regulatory teams to resolve quality issues and escalate risks requiring management review. What you will need Required •Bachelor’s degree in Engineering or a related technical field. •Minimum 5 years of Quality Engineering experience. •Professional proficiency in English and Spanish, written and verbal. •Working knowledge of FDA 21 CFR Part 820, ISO 13485, and MDSAP. •Experience using Microsoft Word and Excel. Preferred •Experience working in the medical device industry or another regulated manufacturing environment. •Experience with CAPA, nonconformance management, FMEA, risk management, statistical sampling, and quality audits. Travel Percentage: 20% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

Staff Quality Engineer (Onsite).

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