Quality Engineer

Stryker is hiring a Quality Engineer in Flower Mound, Texas to support Communications! In this role, you will provide quality engineering support in assurance, control, and preventative activities, focusing on continuous improvement of products and processes. You will lead initiatives and projects to enhance quality performance, ensuring compliance with regulations and standards while delivering value to the business and our customers.

What you will do:

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Collaborate closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.

• Approval of NC/CAPA, builds proficiency in problem-solving and root-causing activities.

• Engage in the development and improvement of manufacturing processes for existing products, review change management activities, and assist in process and equipment validation/qualification.

• Maintain and analyze KPIs for monitoring product/process quality, identify trends, and implement corrective actions.

• Develop proficiency in statistical methods, inspection methods, and sampling optimization.

• Participate in internal and external audits, providing effective narrative and building proficiency in audit interactions.

• Initiate internal containment, support product holds for potential escapes and drive corrective actions by building proficiency in problem-solving and root cause analysis.

• Coordinate with Design Engineering, Regulatory, Manufacturing Engineering, Supplier Quality, and Material teams to conduct risk analysis and resolve non-conformance issues.

• Monitor production performance trends, establish control measures, and drive detection and prevention of non-conformances to reduce scrap/rework costs and ensure customer satisfaction.

• Partner with (Division) Engineering to resolve customer complaints and product field actions associated with in-house production and engage in continuous improvement of manufacturing processes existing products.

• Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.

What you need:

Required:

• BS Degree in engineering or related discipline.

• 0+ years related experience in engineering, quality, or manufacturing.

Preferred:

• Industry experience and familiarity interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.

• Knowledge of US and international Medical Device Regulations.

• Familiarity with ISO 13485, GDP, GMP.

• Understanding of Quality Concepts (Risk Management, CAPA, Audits, Statistics).

• Effective communication, project management, multitasking, and influencing skills.

• Proven ability to manage projects in a matrix organization with critical thinking, problem-solving, and analytical skills.