Staff Quality Compliance Engineer

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

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

HSA

FSAs

401(k)

ESPP

Life and AD&D

Short-term disability

Job summary

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead global regulatory compliance across the product lifecycle. You will guide standards management and ensure medical device quality systems stay aligned with evolving requirements.

You will work with cross-functional teams to assess regulatory changes, perform gap analyses, implement corrective actions, and support internal and external audits.

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.

Responsibilities

• Lead the Standards & Regulations Management Compliance program as the Division Process Owner.
• Monitor and identify new or revised global regulatory requirements, standards, and guidance.
• 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 products and quality system processes.
• Develop and implement compliance action plans to maintain conformity.
• Partner with cross-functional teams to execute compliance activities and ensure documentation is completed.

Skills

Regulatory compliance

Quality engineering

Global medical device regulations

Standards interpretation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Design controls

Risk management

Quality management systems

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

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.