Senior Quality Assurance Engineer (Hybrid)

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Quality Assurance Engineer (Hybrid), in Redmond, Washington to support Medical! 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 in an Operations/Manufacturing environment.

Additionally, you will address supplier quality issues impacting daily operations, advocate for and lead the execution of initiatives and projects to enhance quality performance both within the business and for our customers and ensure compliance with regulations and standards.

Your responsibilities will cover all products manufactured and distributed by Stryker Medical Redmond / Physio-Control.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working 4 days onsite.

Who we want

• 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.

• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you will do

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

• Non-Conformances

  • Collaborate with Divisional QA, cross-functional groups, and Supplier teams to address top quality issues.

  • Own identified internal and supplier-driven Non-Conformances (NC) and manage the timely processing and closure of NCs within the electronic NC management system, Trackwise.

  • Own and support identified internal Corrective Action Preventative Action records (CAPA), managing to timely root cause investigation, implementation, and closure within the electronic CAPA management system, Trackwise.

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

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

  • Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

• Supplier Activities

  • Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.

  • Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval

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

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

• Process Improvements/Validation

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

  • Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

  • Participate in and potentially lead 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 the development and review of process and equipment validation/qualification and MSA of internal processes.

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

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

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

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

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

• Execute internal quality deli