Overview
Senior Quality Systems Specialist (Hybrid) Jobs in Mahwah, NJ at Stryker
Full Job Description
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker’s award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.
Stryker is seeking a Senior Quality Systems Specialist for our Joint Replacement division. This is a hybrid position based in Mahwah, NJ or Weston, FL.
As the Senior Quality Systems Specialist, you will support and enhance our Change Management system, ensuring alignment with global regulatory standards and driving continuous improvement across the Quality Management System (QMS).
What you will do
Manage and improve the Change Management/Change Control process to meet regulatory and business needs
Ensure QMS compliance with FDA, ISO, MDD, and other global regulatory requirements
Support internal and external audits, Management Reviews, and Quality Planning activities
Identify and implement process improvements using data-driven insights and metrics
Collaborate cross-functionally to align QMS with business operations and new product development
Develop and deliver training on Change Management processes and best practices
Maintain and update QMS documentation to reflect current practices and regulatory expectations
Contribute to system integration and IS support for QMS-related processes
What you need
Required
Bachelor’s degree in Science, Engineering, Business, or a related discipline
Minimum 3 years of experience in a manufacturing environment or equivalent
Experience in a regulated environment with direct interaction with regulatory agencies
Preferred
Thorough knowledge and understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Systems (CAPA, change control, audits, Management Review, Quality Planning, etc.)
$69,100.00 – $128,900.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Title: Senior Quality Systems Specialist (Hybrid)
Company: Stryker
Location: Mahwah, NJ
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