Sr Engineer, Quality Assurance Engineering

Stryker•Irvine, CA

8d•Onsite

About The Position

Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site. What You Will Do Provide quality and validation engineering support to ensure compliance with applicable regulations, standards, and internal procedures. Lead and advocate for quality initiatives focused on preventative measures, continuous improvement, and risk reduction across products and processes. Oversee, review, and approve Non‑Conformances (NCs), CAPAs, and root‑cause investigations, mentoring teams in structured problem‑solving methodologies. Support and approve change management activities, ensuring effective risk evaluation and regulatory compliance. Provide subject‑matter expertise for process, equipment, and computer system validation/qualification, including review and approval of validation documentation. Actively participate in the development and improvement of manufacturing processes for existing and new products. Support execution, analysis, and review of Quality Acceptance Tests (QATs) and First Article Inspections. Lead and contribute to risk management activities, applying tools such as FMEAs, FTAs, and other risk‑based techniques. Serve as site owner for at least one validation specialty, acting as the primary technical resource and validation contact. Interface with internal and external auditors and regulatory bodies, providing clear and effective technical narratives within your area of expertise. Collaborate cross‑functionally to ensure quality and validation considerations are effectively integrated into operational and project decisions. What You Need Bachelor’s degree in engineering Minimum 2 years of experience in quality, engineering, validation, or a heavily regulated environment. Preferred Engineering degree in Mechanical, Electrical, Chemical, or Biomedical Engineering. 2+ years of experience in quality, engineering, validation, or regulated manufacturing environments. Experience supporting R&D, New Product Development (NPD), New Product Introduction (NPI), or Commercial Operations activities. Familiarity with ISO 13485, GMP, GDP, and medical device manufacturing processes. $89,400.00 - 148,900.00 USD Annual salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10% 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. 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. 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. 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.

Requirements

Bachelor’s degree in engineering
Minimum 2 years of experience in quality, engineering, validation, or a heavily regulated environment.

Nice To Haves

Engineering degree in Mechanical, Electrical, Chemical, or Biomedical Engineering.
2+ years of experience in quality, engineering, validation, or regulated manufacturing environments.
Experience supporting R&D, New Product Development (NPD), New Product Introduction (NPI), or Commercial Operations activities.
Familiarity with ISO 13485, GMP, GDP, and medical device manufacturing processes.

Responsibilities

Provide quality and validation engineering support to ensure compliance with applicable regulations, standards, and internal procedures.
Lead and advocate for quality initiatives focused on preventative measures, continuous improvement, and risk reduction across products and processes.
Oversee, review, and approve Non‑Conformances (NCs), CAPAs, and root‑cause investigations, mentoring teams in structured problem-solving methodologies.
Support and approve change management activities, ensuring effective risk evaluation and regulatory compliance.
Provide subject‑matter expertise for process, equipment, and computer system validation/qualification, including review and approval of validation documentation.
Actively participate in the development and improvement of manufacturing processes for existing and new products.
Support execution, analysis, and review of Quality Acceptance Tests (QATs) and First Article Inspections.
Lead and contribute to risk management activities, applying tools such as FMEAs, FTAs, and other risk‑based techniques.
Serve as site owner for at least one validation specialty, acting as the primary technical resource and validation contact.
Interface with internal and external auditors and regulatory bodies, providing clear and effective technical narratives within your area of expertise.
Collaborate cross‑functionally to ensure quality and validation considerations are effectively integrated into operational and project decisions.