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Quality Engineer, Service

Quality Engineer, Service
Company:

Stryker


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 Quality Engineer – Service, in Kalamazoo, Michigan, supporting Instruments ! In this role, you will support the Service Repair Depot to ensure adherence to Stryker's Quality System while minimizing customer downtime and identifying opportunities for continuous improvement for existing products and provide input on Service for new product development.
Who we want: Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partners
Collaborative Partners .  Relationship-savvy people who intentionally make connections, listen to others' ideas, and work together to move the business forward.
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.
What you will do: Fully support the Quality needs of the Depot Service, Field Service, Loaner, Refurb, and Non-Serviced Device teams. This includes validation support and nonconformance documentation.
Conduct risk assessments on product and process nonconformances to determine patient/user health risk; develop and document action plan to address discrepancies.
Evaluate and document product nonconformances in a timely manner to minimize customer downtime.
Provide input for product development of serviceable product; support validation of new equipment and fixtures; create new quality inspection procedures for product acquisitions intended to be serviced.
Review and comprehend applicable Quality System Procedures, ensuring compliance to the procedures. Create or update procedures as necessary.
Prepare monthly presentations for cross-department assessment utilizing various sources of data from ERP systems, complaint databases and customer feedback.
Prioritize and manage multiple projects within process/design specifications and budget restrictions.
Participate in cross-functional teams to identify and define product/process improvement opportunities.
Initiate, communicate, manage, and lift Local (Ship) Holds.
Partner with supporting engineering staff to resolve line-down issues.
Conduct internal audits of the Service unit and investigate audit findings.
May travel as needed to customer accounts to provide product expertise and observe utilization practices.
What you will need: Required:
Bachelor's Degree in Engineering or related discipline
0+ years' experience in engineering
Preferred:
Experience in medical device development and/or manufacturing (regulated environment) preferred.
Working knowledge of FDA, ISO, and other regulations and standards preferred.
Working knowledge of Risk Analysis, Root Cause Analysis, Statistics and practical applications preferred.
ASQ Certifications (CQE, CRE, CQM, CSSBB) preferred.
Ability to generate, follow and explain detailed quality requirements and investigation procedures.
Effectively communicate product deficiencies and data conclusions to internal and external customers.
Ability to identify and analyze non-routine product issues using independent judgment and inspection equipment.
Capable to assess a situation, gather the necessary facts, and couple it with prior experiences and knowledge to make decisions on how to move forward toward the ideal solution.
Excellent analytical and problem-solving skills.
Strong organizational and communication skills.
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.


Source: Grabsjobs_Co

Job Function:

Requirements

Quality Engineer, Service
Company:

Stryker


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