Hybrid
Full Time Posted 3 days ago
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Job Type

Full Time

Job Details

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.

Joint Replacement is hiring a Senior QMS Specialist, Field Quality (Remote)! In this role, you will play a pivotal role in developing and maintaining the quality management system to ensure compliance with all relevant regulatory requirements for medical devices.

Our Field Quality Teams support US branches in temperature monitoring, torque calibration devices, cycle counting, internal/external audits, document control and NC/CAPA management. You’ll drive compliance and promote best practices across the US Field, ensuring consistent and high-quality standards!

What you will do:

  • You will oversee, support, and ensure that an effective and efficient quality management system is built and maintained

  • You will assist in driving and providing oversight of QMS elements for US Field Operations

  • You will support QMS compliance with relevant internal and external regulatory requirements

  • You will participate in developing an optimized future state of the QMS to align with business needs

  • You will identify and implement improvement opportunities to increase QMS efficiency and effectiveness

  • You will support the development and delivery of QMS training

  • You will contribute to the creation, maintenance, and improvement of QMS policies and procedures

  • You will support internal and external quality system audits

  • You will manage field-related NCs and CAPAs, including ownership and documentation.

What you need:

Required:

  • Bachelor’s degree preferred; in lieu of degree equivalent experience will be considered.

  • 2+ years relevant working experience required.

  • Experience in a regulated environment, including interaction with regulatory agencies. Preferably in the medical device sector.

Preferred:

  • ERP system experience (e.g., Oracle, SAP)

  • OnePLM experience

  • WebOps experience

  • NC/CAPA (Nonconformance and Corrective Action/Preventive Action) experience

  • Quality Systems experience

  • Strong influencing skills with the ability to gain alignment for strategic field operations initiatives

  • Ability to obtain AATB (American Association of Tissue Banks) certification within 3 months of hire

  • Experience leading complex, transformational initiatives in inventory management, quality, auditing, or operations

  • Demonstrated ability to apply technical applications to improve business processes

Other:

  • Travel will range from 20-30%

$67,400- $136,200 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.
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Senior QMS Specialist, Field Quality (Remote)
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