Senior Engineer, Quality Process

Stryker is hiring a Senior Quality Engineer in Phoenix, Arizona, to support Sustainability Solutions! In this role, you will be responsible for analyzing and resolving production issues through collaboration with engineering and material procurement teams. Furthermore, you will perform monitoring of process data and analysis of trends, financial results, and customer feedback. You will exhibit a commitment to quality first culture, compliance, and continuous improvement through the implementation of projects which optimize production, inspection, and quality system processes. 

What you will do

• Work closely with operations and the business functions to ensure quality performance of product and processes
• Collaborate cross-functionally with internal and external teams to resolve quality issues
• Manages internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
• Owns Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
• Disposition of non-conforming product through MRB, issuing NCs as appropriate
• Initiates and leads in the development and improvement of the manufacturing processes for existing and new products.
• Review and approval of change management activities, challenges change effectiveness and drives strong review.
• Interpret KPI trends, act as necessary, driving a continuous improvement process.
• Support the execution and analysis of manufacturing complaints and product field actions
• Provide QA support during internal and external audits
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and concepts and applies knowledge to manufacturing operations and identify opportunities and weaknesses
• Lead and participate in the Lean philosophy – standardization and elimination of waste
• Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
• Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
• Support with product holds and executing containment plans
• Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.
  

What you need

• B.S. in engineering, or related discipline
• 2+ years as a Quality Engineer in a manufacturing environment.

Preferred

• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
• Lean Six Sigma training is a distinct advantage.
• Excellent communication skills and attention to detail.
• Proficient understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Confident representing Quality in cross-functional settings
• Self-starter able to manage multiple tasks in a fast-paced environment
• Willing to work as part of a multi-site team; some travel required

United States of America Pay Ranges:

• Puerto Rico: $69,500 - $110,900 USD Annual
• USN: $77,700 - $129,500 USD Annual
• US5: $81,600 - $136,000 USD Annual
• US10: $85,500 - $142,500 USD Annual
• US15: $89,400 - $148,900 USD Annual
• US20: $93,200 - $155,400 USD Annual
• US30: $101,000 - $168,400 USD Annual