Staff Quality Compliance Engineer

Stryker Corporation; Irvine (CA); On-site; Confidential; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking a Staff Quality Compliance Engineer to lead regulatory compliance across the product lifecycle, ensuring alignment with evolving global regulations. This role provides technical leadership for standards management and supports audits.

You will collaborate with cross-functional teams to assess regulatory changes, perform gap analyses, and implement corrective actions to maintain conformity of products and quality systems.

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 in 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: experience supporting internal and external regulatory or quality audits.

Responsibilities

• 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.

Skills

Regulatory compliance

Quality engineering

Design controls

Risk management

Global regulations

Cross-functional collaboration

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: None

Stryker 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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Work Flexibility Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Work Flexibility Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Work Flexibility Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co‑located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.