Work Flexibility: Remote
Responsible for independently leading internal audits to assess compliance and effectiveness of the Quality Management System (QMS). Partners with site stakeholders to drive compliance, identify risks, and support continuous improvement.
Lead internal audits from planning through execution, reporting, and follow-up
Develop and tailor audit scope, agenda, and plans based on site inputs
Assess compliance to FDA, ISO 13485, MDR/MDD, and company procedures
Document audit results, including nonconformances and observations
Present audit results and insights to site leadership
Support execution of the Global Internal Audit Program
Monitor audit observations and escalate trends or systemic risks
Interface with Site RAQA and Quality leadership teams
Required:
Bachelor’s degree i n engineering, science, business administration or related field.
Certified Lead Auditor (or equivalent quality auditing certification) required
At least 2 years of experience auditing in a regulated industry
Fluent in both English and Spanish required
Working knowledge of FDA and ISO 13485 requirements
Preferred:
Auditing experience in medical device or pharmaceutical industries
Travel Percentage: 40%
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 40 years of sales growth leading up to 2020
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 7 consecutive years as one of Fortune's World's Best Workplaces
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