Staff Quality Engineer

Work Flexibility: Onsite

Stryker is hiring a Staff 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.

Who we want:

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do:

• Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.

• Mentor and provide technical direction across multiple areas of expertise.

• Ensure compliance to regulation and standards.

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

• Collaborates with Divisional QA, cross functional and suppliers’ teams to address top quality issues.

• Own identified internal and supplier non-conformances/manage the timely closure of nonconformances.  

• Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.

• Disposition non-conforming product within MRB, issuing NC's as appropriate.

• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

• Engage in the development and improvement of internal manufacturing processes for existing products.

• Perform critical assessment of internal and supplier proposed change management activities. 

• Performs PPAP activities for supplier changes

• Participates and may lead in the creation and/or review of new or modified procedures. 

• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

• Support execution and analysis of manufacturing related complaints and product field actions.

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

• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification. 

• Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.

• Support the creation and maintenance of inspection methods and sampling.

• Applies statistical methods of analysis and process control to current operations.

• Engage and interface in internal and external audits providing subject matter expertise                                                                      

• Support the development and review of process and equipment validation/qualification and MSA of internal processes.

• Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. 

• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

• Responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes. 

• Drive continuous improvement actions to reduce manufacturing defects.            

• Provide leadership and subject matter expertise in QA activities to the overall site.

What you need:

Required:

• Bachelor’s degree in science, engineering, or related discipline.

• 4+ years’ experience in quality, engineering, manufacturing and/or operations within a highly regulated industry.

Preferred:

• Experienc