Staff Quality Systems Specialist

Stryker is hiring a Staff Quality Systems Specialist for our Medical division supporting our Stryker Sage business unit in Cary, IL who will be responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices, drugs, and cosmetics. The Quality Systems Specialist will oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification.

What you will do:

• Ensure compliance with applicable regulatory and quality standards, including FDA, ISO 13485, MDR, GMP, GDP, and corporate requirements.

• Lead the development, implementation, and continuous improvement of Quality Systems to support business objectives and regulatory compliance.

• Serve as a subject matter expert and process owner for assigned Quality Management System (QMS) processes.

• Identify, evaluate, and implement process improvements to enhance Quality System effectiveness, efficiency, and inspection readiness.

• Develop, maintain, and improve quality policies, procedures, and documentation to support operational and regulatory requirements.

• Lead Quality Systems initiatives and cross-functional projects, applying project management principles to achieve key milestones and deliverables.

• Support internal and external audits, regulatory inspections, and certification activities, including interactions with notified bodies and audit response activities.

• Develop and deliver training, provide guidance to stakeholders, and promote Quality Systems best practices across the organization.

What you need:

Required:

• Bachelor's degree in Science, Engineering, Business, Quality, or a related discipline.

• Minimum of 4 years of experience supporting Quality Systems within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, cosmetics, manufacturing, aerospace, or other regulated environments).

• Experience developing, implementing, maintaining, and/or continuously improving Quality Management System (QMS) processes, procedures, and documentation.

• Working knowledge of core Quality Systems elements such as document control, change management, risk management, validation, or design controls.

• Experience supporting compliance activities, identifying quality or compliance risks, and driving appropriate documentation, escalation, and resolution.

Preferred:

• Experience participating in Quality System integration, harmonization, merger, acquisition, or transformation initiatives across sites, business units, or organizations.

• Strong technical writing and documentation experience, including development or standardization of procedures, work instructions, quality records, validation documentation, or integration plans.

$91,600 - $152,700 USD Annual

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.