Staff Quality Compliance Engineer

Stryker • Irvine, CA

3d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level