Staff Quality Compliance Engineer

$102.7k - $171.1k

Stryker

Irvine, CA

Responsibilities

Lead Standards & Regulations Management Compliance program as Division Process Owner
Monitor and identify new or revised global regulatory requirements and standards applicable to medical devices
Interpret regulatory requirements and provide guidance to product development and quality teams
Conduct gap assessments comparing updated regulations to existing processes and requirements
Develop and implement compliance action plans to maintain product and quality system conformity

Requirements

Bachelor's degree in Engineering or related discipline
Minimum 4 years regulatory compliance, quality, or engineering experience
Medical device, healthcare, or regulated industry background
Experience conducting regulatory impact assessments and standards gap analyses
Knowledge of design controls, risk management, and quality management systems
Understanding of global medical device regulations and international standards
Experience supporting internal and external regulatory or quality audits (preferred)

Compensation: $102,700 - $171,100 USD Annual

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Vacancy posted 6 days ago

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