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 in 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
Skills Required
- Bachelor's degree in engineering, science, business administration, or related field
- Certified Lead Auditor or equivalent quality auditing certification
- At least 2 years of experience auditing in a regulated industry
- Fluent in both English and Spanish
- Working knowledge of FDA and ISO 13485 requirements
- Auditing experience in medical device or pharmaceutical industries
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Healthcare coverage is described as comprehensive, with multiple medical plan options and added protections such as critical illness, accident, and hospital indemnity, plus mental health resources. Wellbeing programs, onsite gyms, and fitness/nutrition classes further reinforce the perceived strength of health benefits.
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Retirement Support — Retirement offerings are seen as strong, highlighted by a competitive 401(k) plan with company matching and potential discretionary contributions. These elements are often viewed as valuable pillars of total rewards.
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Strong & Reliable Incentives — Variable pay is viewed positively, with annual bonuses and sales commissions often lifting total compensation. Incentive plans are seen as a meaningful contributor to pay satisfaction in roles where performance drives earnings.
Stryker Insights
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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