Principal Quality Engineer (CAPA)

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 07-11-2025

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

The Principal Quality Engineer (CAPA) is responsible for leading the Inari Division CAPA program to ensure corrective and preventive actions are addressed in conformity with applicable global regulatory requirements and standards. Candidates must be within commutable distance of Irvine CA.

What you will do

As the Inari Divisional Process Owner (DPO) of the CAPA subsystem this role is responsible for managing and maintaining open CAPAs in the electronic TrackWise system.
Providing expertise training and guidance in performing root cause analysis using appropriate investigation techniques.
Conducting risk assessments to determine the impact of systemic non-conformities on QMS product and/or process.
Developing detailed corrective and preventive action plans to address root cause(s) of existing and potential nonconformities.
Leading efforts with cross-functional partners to execute action plan(s) ensuring that corrective and preventive actions do not adversely affect the finished product patient safety or regulatory compliance.
Determining methodology for evaluating the effectiveness of corrective or preventive actions using appropriate statistical techniques.
Performing data trending and analysis of CAPA metrics and presenting findings to cross-functional leadership.
Ensuring that all activities are performed and documented per company policies and procedures intended to assure product safety and effectiveness.
Initiating leading and executing quality system improvement projects with substantial impact.
Demonstrating appropriate risk-based decision making and prioritizing key activities to maintain product conformity and QMS compliance.
Supporting internal and external QMS audits as Subject Matter Expert for corrective and prevent actions within the product lifecycle and QMS.

What you need

Bachelors degree in engineering discipline .
Minimum of 8 years of related work experience with a strong understanding of corrective and preventive actions.
Experience in medical devices or related industries.
Strong knowledge of CAPA as it relates to Quality Management Systems internal and external audits product design controls and risk management.

Preferred

Ability to manage competing priorities in a fast-paced and dynamic environment.
Strong problem-solving organizational analytical and critical thinking skills.
Excellent proven interpersonal verbal and written communication skills.

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 contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: OnsiteThe Principal Quality Engineer (CAPA) is responsible for leading the Inari Division CAPA program to ensure corrective and preventive actions are addressed in conformity with applicable global regulatory requirements and standards. Candidates must be within commutable distance...

Work Flexibility: Onsite

What you will do

As the Inari Divisional Process Owner (DPO) of the CAPA subsystem this role is responsible for managing and maintaining open CAPAs in the electronic TrackWise system.
Providing expertise training and guidance in performing root cause analysis using appropriate investigation techniques.
Conducting risk assessments to determine the impact of systemic non-conformities on QMS product and/or process.
Developing detailed corrective and preventive action plans to address root cause(s) of existing and potential nonconformities.
Leading efforts with cross-functional partners to execute action plan(s) ensuring that corrective and preventive actions do not adversely affect the finished product patient safety or regulatory compliance.
Determining methodology for evaluating the effectiveness of corrective or preventive actions using appropriate statistical techniques.
Performing data trending and analysis of CAPA metrics and presenting findings to cross-functional leadership.
Ensuring that all activities are performed and documented per company policies and procedures intended to assure product safety and effectiveness.
Initiating leading and executing quality system improvement projects with substantial impact.
Demonstrating appropriate risk-based decision making and prioritizing key activities to maintain product conformity and QMS compliance.
Supporting internal and external QMS audits as Subject Matter Expert for corrective and prevent actions within the product lifecycle and QMS.

What you need

Bachelors degree in engineering discipline .
Minimum of 8 years of related work experience with a strong understanding of corrective and preventive actions.
Experience in medical devices or related industries.
Strong knowledge of CAPA as it relates to Quality Management Systems internal and external audits product design controls and risk management.

Preferred

Ability to manage competing priorities in a fast-paced and dynamic environment.
Strong problem-solving organizational analytical and critical thinking skills.
Excellent proven interpersonal verbal and written communication skills.

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Design
Academics
AutoCAD 3D
Cafe
Fabrication
Java

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click