Principal Quality Engineer (CAPA)

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.