Senior Staff Engineer, Quality Assurance

Senior Staff Engineer, Quality Assurance
Company:

Stryker Orthopaedics


Details of the offer

Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products.  You will also have growth opportunities as we have a culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting 
Stryker is hiring a Senior Staff QA Engineer for our Global Quality Operations team in Kalamazoo, MI.
Who we want –
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. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 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.
Collaborates with Divisional QA, cross-functional and suppliers' teams to address top quality issues. Own identified internal and supplier driven non-conformances and manage the timely closure of nonconformances within.                    Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.  Disposition non-conforming product within MRB, issuing nonconformances as appropriate. Communicate with suppliers regarding non-conformances, escalating supplier corrective action requests as required. Engage in the development and improvement of the internal manufacturing processes for existing products. Performs critical assessment of internal and supplier proposed change management activities. Participates 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. Advocate of 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. Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes What you need: Bachelor of Science or in an Engineering discipline required. 6+ years' experience in a manufacturing or quality environment required. Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). Able to demonstrate strong communication, project management and ability to influence without authority.  Able to demonstrate the ability to manage multiple tasks simultaneously. Ability to represent Quality function with project teams. Strong interpersonal skills, written, oral communication and negotiations skills. Strong in critical thinking and 'outside the box' thinking. Highly developed problem-solving skills. Strong analytical skills. Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently and as part of cross-functional teams. About Stryker Our benefits:

12 paid holidays annually
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.
For a more detailed overview of our benefits or time off, please follow this link to learn more:  US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at  stryker.com.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our  referral page
Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.


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Job Function:

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Senior Staff Engineer, Quality Assurance
Company:

Stryker Orthopaedics


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