Staff Quality Engineer (Onsite)

About the role

Stryker is hiring a Staff Quality Engineer on site to support Quality Assurance activities in a regulated medical device environment. The role partners with Manufacturing, Research & Development, Regulatory and Engineering teams to 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).

Key responsibilities

• Investigate product and process quality issues with cross-functional teams, performing risk assessments, historical record reviews, nonconformance evaluations and corrective actions.
• Coordinate containment and disposition of nonconforming product, including identification, segregation, reconciliation and documented resolution.
• Monitor and trend quality data to spot potential issues and give 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 set up sampling plans and evaluate the effectiveness of corrective actions.
• Interpret risk management documentation such as FMEA to support quality and risk-based decisions.
• Support internal and external audits, respond to audit findings and evaluate Quality Management System changes needed to stay compliant.
• Partner with QA, Manufacturing, Engineering, R&D and Regulatory teams to resolve quality issues and escalate risks needing management review.

Required profile

• Bachelor's degree in Engineering or a related technical field.
• At least 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.
• Preferred: experience in the medical device industry or another regulated manufacturing environment.

Required skills

• Microsoft Word and Excel.
• Preferred: CAPA, nonconformance management, FMEA, risk management, statistical sampling and quality audits.