Staff Quality Engineer

Staff Quality Engineer

Stryker is hiring Staff Quality Engineer in Sandy Springs, GA! 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 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.

• 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.
• Perform critical assessment of internal and supplier proposed change management activities. 
• Performs PPAP activities for supplier changes
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• 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.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

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:

• 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.