Senior Quality Engineer - Post Market

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: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

Main purpose of role

As a Quality Engineer on the Post Market Surveillance Safety Reporting Team you will be responsible for monitoring the safety and performance of Joint Replacement products. You will employ various statistical tools and methodologies to analyze post market data, develop metrics and communicate any conclusions with business partners such as Design Assurance, Regulatory Affairs and Product Development.

Key tasks

• Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations
• Author Post market plans/reports on JR products sold worldwide.
• Evaluate safety data and signals as a part of ongoing pharmacovigilance activities.
• Lead and support identification of trends and patterns and interpretation of data in safety assessment and evaluation.
• Apply clinical judgment to identify missing pertinent medical data required for a complete adverse event case.
• Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for Health Authority review boards.
• Liaise with other relevant functional areas both within and outside of global PV to best ensure the most efficient and timely attainment of compliant and patient focused safety data.
• Provide technical expertise in data analysis, data preparation and performance monitoring
• Build, manage and maintain reports, dashboards and visualizations as needed.
• Communicate key findings to business partners and leadership throughout the organization
• Help develop automated solutions for dashboard and report generation

Qualifications, skills and desirable experience

• Bachelor's Degree in Engineering, Statistics or a related field
• 5+ years of experience
• Previous work experience in a regulated environment required
• Good analytical and problem-solving skills.
• Experience with Microsoft Power BI preferred
• Proficient computer skills in advance excel and word.
• Understanding of databases and data warehouses preferred
• Prior experience using complaints processing software (good to have)

Soft Skills: -

• Excellent documentation and communication skills.

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com