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Job description
Stryker is hiring a Senior Quality Engineer in Arlington, TN to support Trauma and Extremities! In this role, you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. You will be an advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
What you will do:
Collaborate with Divisional QA, cross-functional teams, and suppliers to address top quality issues, ensuring product and process quality performance.
Manage non-conformances (NCs) and corrective/preventive actions (CAPAs) with timely root cause investigations, implementation, and closure.
Oversee non-conforming product disposition, communicate with suppliers regarding NCs, and escalate supplier corrective actions when required.
Support the development, improvement, and change management of internal manufacturing processes, including PPAP activities for supplier changes.
Maintain and analyze KPIs, identifying trends and activating appropriate corrective actions to ensure quality standards.
Engage in internal and external audits, provide subject matter expertise, and execute quality deliverables for engineering changes and manufacturing transfers.
Apply risk management practices, statistical methods, and human factors science to reduce defects and support process and equipment validation.
Lead and drive continuous improvement initiatives, providing QA leadership and expertise across the site.
What you will need:
Required:
Bachelor's degree or higher in a Science or engineering related discipline.
2+ years of experience in quality, engineering, manufacturing and/or operations within a highly regulated industry.
Preferred:
Experience with ISO14971 and ICHQ9 risk management standards and guidance.
Experience in working in a compliance risk situation.
Strong quality background with CQE and / or Six Sigma Green or Blackbelt preferred.
Expertise in Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).
Strong interpersonal skills, written communication, oral communication, and negotiations skills.