Senior Quality Systems Specialist (Hybrid)
Stryker
Date: 1 day ago
City: Weston, Florida
Salary:
$69,100
-
$128,900
per year
Contract type: Full time
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
What you need
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.
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
- 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
- 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.)
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.
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