Staff Quality Compliance Engineer

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

Job summary

Stryker in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead regulatory compliance across the product lifecycle. You will guide standards programs and support cross-functional teams to ensure products and quality systems stay aligned with evolving global requirements.

The role emphasizes regulatory impact assessments, gap analyses, and implementing compliant actions across development, manufacturing, and quality processes. Onsite work with minimal travel is required.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 4+ years in regulatory compliance, quality, engineering, or related function.
• Experience in medical device/regulated industries.
• Experience with regulatory impact assessments and gap analyses.
• Experience with design controls, risk management, and quality 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 for medical devices and quality systems.
• Interpret regulatory requirements and provide guidance to teams responsible for product development, sustaining engineering, and quality management.
• Conduct gap assessments comparing new or updated regulations 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 across products and processes.
• Partner with cross-functional teams to execute compliance activities and ensure required documentation is completed.
• Support audits as a subject matter expert and review documentation for regulatory conformity.

Skills

Regulatory compliance

Quality engineering

Design controls

Risk management

Quality management systems

Global regs

Education

Bachelor's degree in Engineering

Job description

Work Flexibility: Onsite

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

Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.