Job Information
Stryker Senior Quality Assurance Engineer (Hybrid) in Redmond, Washington
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
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 deliverables associated with engineering changes, manufacturing transfers, and supplier-initiated changes.
What you need
Required Qualifications
Bachelor’s degree in science, engineering, or related discipline. Preferred to be in Electrical, Mechanical, Industrial or Biomedical Engineering.
2+ years’ experience in quality, manufacturing and/or engineering.
Preferred Qualifications
Strong quality background with CQE and / or Six Sigma Green or Blackbelt preferred.
Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.). Experience in working in a compliance risk situations.
Expertise in Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS). Proficient use of electrical, mechanical, or environmental procedures, quality control testing equipment and methods.
Strong project management, leadership, and influencing skills as well as ability to manage multiple tasks simultaneously.
Demonstrated ability to successfully manage and complete projects in a matrix organization as well as to work independently and as part of cross-functional teams.
Strong interpersonal skills, written communication, oral communication, and negotiations skills.
$75,300.00 - 156,900.00 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.