Senior Product Complaints Specialist- Post Market

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker is seeking a Senior Product Complaints Specialist to support Trauma and Extremities products in Arlington, Tennessee.

WHO WE WANT:

• Collaborative partners. People who build and leverage cross-functional relationships to bring

together ideas, information, use cases, and industry analyses to develop best practices.

• 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. 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:

As a complaint handling specialist for medical devices, you are responsible for the structured investigation of claimed products. You will perform device inspection and root cause analyses on these claimed products and based on your findings initiate corrective actions if necessary. Moreover, you analyze engineering data, test certificates, risk evaluations and compile trending. In this context you are responsible for the documentation (in English) of complaint data and test results in the global complaint system (CHS / TrackWise / suPER). In this role, you’ll work closely with other departments (e.g. R & D, manufacturing, RAQA, marketing, logistics, customer services) and attending meetings. Regular reporting as well as accurate data analysis is also part of your field of action.

• Processing investigations of medical complaints

• Determining the cause of complaint (root cause)

• Perform a device inspection when possible or coordinate with the inspection cells

• Introduction of necessary corrective measures (NC / CAPA)

• Analyzing production documents, test certificates, risk assessments (risk management file), directions (Optech), processing instructions (IFU / Reprocessing) etc.

• Creation of statistical analysis (Trending)

• Documentation of complaint data and test results in the global complaint system (CHS / TrackWise / suPER).

• Connect with other department (R & D, manufacturing, RA, marketing, logistics, customer services) and attending meetings

• Coordinate investigations on early product surveillance process

• Coordinate potential recurring situation board with R&D / complaint handling team

• Provide necessary information to regulatory compliance team for reporting

• Train the new employees

• Participate on department improvement

WHAT YOU NEED:

• Bachelor’s degree - required. Bachelor’s Degree in engineering or Science - preferred

• 3+ years related work experience - required

• 1+ years Medical Device Post Market Complaints experience - preferred

• Previous experience with NC/CAPA - preferred

• Previous experience in a regulated industry - required

• Previous audit support, documentation review - preferred

• Previous experience conducting root cause analysis or complaint handling - preferred

• Previous experience using ERP programs including (TrackWise, suPER, SAP, Tableau) - preferred

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 at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

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.com