Staff Quality Compliance Engineer

Stryker Group; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker Group in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will provide technical leadership for standards management, assess regulatory changes, and implement actions to keep products and quality systems aligned with evolving requirements.

You will collaborate with cross-functional teams, support audits as a subject matter expert, review test protocols and reports for regulatory conformity, and guide teams

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 4 years in regulatory compliance, quality, or engineering.
• Experience in medical device or regulated industries.
• Experience with regulatory impact assessments and standards gap analyses.
• Knowledge of design controls, risk management, and quality systems.
• Familiar with global medical device regulations and international standards.

Responsibilities

• Lead the regulatory compliance program as Division Process Owner across divisions.
• Monitor global regulatory requirements and applicable standards for medical devices.
• Interpret regulations and provide guidance to product development and quality teams.
• Conduct gap assessments between new regulations and current processes.
• Evaluate impact of changes on products and QMS processes.
• Develop and implement action plans to maintain conformity.
• Support audits and review documentation for regulatory conformity.

Skills

Regulatory compliance

Quality engineering

Risk management

Design controls

Global standards knowledge

Education

Bachelor's degree in Engineering

Job description

Staff Quality Compliance Engineer

Irvine, CA

Join Stryker in a key role supporting global regulatory compliance across the product lifecycle. This position provides technical leadership for standards and regulations management, ensuring medical device products and quality systems remain aligned with evolving global regulatory requirements. The role partners closely with cross-functional teams to assess regulatory changes, evaluate impact, and implement compliance actions across products and processes.

What You Will Do

• Lead the Standards & Regulations Management Compliance program as the Division Process Owner, aligning processes and compliance activities across divisions.
• Monitor and identify new or revised global regulatory requirements, standards, and guidance applicable to medical devices and quality systems.
• Interpret regulatory requirements and standards and provide guidance to teams responsible for product development, sustaining engineering, and quality management.
• Conduct gap assessments comparing new or updated regulations and standards to existing requirements and processes.
• Evaluate the impact of regulatory and standards changes on commercialized products and quality management system processes.
• Develop and implement compliance action plans to maintain product and quality system conformity.
• Partner with cross-functional teams to execute compliance activities and ensure required documentation is completed according to company procedures.
• Support internal and external audits as a subject matter expert and review technical documentation, test protocols, and reports for regulatory conformity.

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering, or related discipline.
• Minimum 4 years of experience in regulatory compliance, quality, engineering, or a related function.
• Experience working within the medical device, healthcare, or regulated industry.
• Experience performing regulatory impact assessments and standards gap analyses.
• Experience with design controls, risk management, and quality management systems.
• Knowledge of global medical device regulations and international standards.

Preferred Qualifications

• Experience supporting internal and external regulatory or quality audits.

• $102,700 - $171,100 USD Annual