Quality Lead Representative - 1st Shift - Starting rate $27.32/hr

Location

Portage, MI | United States

Job description

Why RA/QA 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance 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 

Schedule : Monday-Friday, 8:00am-5:00pm

Flexibility with start time

Who we want –

• Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.  You will be the face of Stryker!
• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
• 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.
• 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 –

As a Post-Market Quality Lead Representative, you will provide support to the Post-Market Quality team that is responsible for both domestic and international complaint handling along with the product field action team. Specifically, this position is responsible for the coordination of material and information to meet quality and regulatory requirements. 

• ​Provide updates within quality management system, Trackwise, on status of product field action executions. 
• ​Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams. 
• ​Provide updates within Trackwise on the status of event detail information and product returns to support complaint-handling activities. 
• ​Work with internal and external partners on the facilitation of the movement of complaint return products. 
• ​May support international and domestic complaint entry. 
• ​Support management with various weekly, monthly and quarterly reporting as needed. 
• ​Work with internal supporting teams on quality of data coming into post market. 
• ​May monitor, create and assign regulatory communications to quality specialists for resolution. 
• ​Involvement in team projects as requested.​ 
• Develop basic knowledge and understanding of complaint handling and product field action process as required by regulatory agencies.

What you need

• 5+ years of experience – require
• High School diploma or equivalent – required
• Associates Degree – preferred
• Ability to work flexible hours, as needed to support the business needs, including weekend and evening call as needed – required
• Experience in a regulatory or compliance environment – preferred
• Technical experiences with quality management systems such as Trackwise or customer relationship management systems such as Salesforce – a plus

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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