Staff Engineer, Quality

Work Flexibility: Onsite

This is a 23 month contract with Stryker benefits.

What You Will Do:

Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. 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.

• Experience in interacting with regulatory agencies (FDA, BSI, etc.) desired
• Familiarity with ISO 13485, GDP, GMP required
• Strong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)
• 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 and manage the timely closure of NC’s
• Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure
• Disposition non-conforming product within MRB, issuing NCs as appropriate
• Communicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required
• Engage in the development and improvement of internal manufacturing processes for existing products
• Performs 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.

What You Will Need:

• BSc in a science, engineering or related discipline
• Six Sigma Green or Black belt preferred.
• Minimum of 4 years’ experience preferred

Travel Percentage: None