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Job description
Stryker is hiring a Specialist, Post Market Quality in Portage, MI supporting Instruments! In this role, you will 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.
Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Portage, MI. You should be comfortable working 3-days onsite.
What you will do
Participation in product field action strategy meetings.
Creation and mailing of customer letters for product field action notification.
Communicate directly with customers to perform product field action effectiveness checks on open actions.
Coordination with customer care teams on replacement products and credits.
Communicate with internal and external resources globally on product field action execution activities.
Provide updates within 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 status of event detail information and product returns to support complaint handling activities.
Work with internal and external partners on the facilitation of movement of complaint return product.
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.
What you need
Required:
Bachelor’s Degree or higher with no prior work experience necessary.
Preferred:
Bachelors degree or higher in Regulatory Science, Engineering, Science related discipline.
Regulatory Affairs Certification (RAC) preferred.
Proven experience in regulated industries, with a strong preference for the medical device sector.
Expertise in post-market quality processes, including complaint handling and product field action process as required by regulatory agencies.