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 

Bachelor's degree in engineering discipline required. 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 contractor’s legal duty to furnish information.