Engineer I, Quality (THV)

Job Title: Engineer, Quality (THV)

• Engineer I, Quality (THV)
• Engineer II, Quality (THV)
• Engineer III, Quality (THV)

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Quality Engineering

Job Location & Environment: Irvine, CA- Corporate office / Controlled Cleanroom Environment

Job Description Summary:

• Provide regular Quality Engineering support to transcatheter Heart Valve (THV) manufacturing and relevant areas including design Verification and Validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance identification/initiation/investigation, risk management, and post-market assessment.

Job Responsibilities:

• Partner with Manufacturing Engineers to characterize and qualify manufacturing processes.
• Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures.
• Review of documentation and production records to ensure all product is produced in compliance with QSRs and ISO standards and ensure all Device History Records (DHR) are complete, accurate and compliant to Good Documentation Practice (GDP).
• Review and update device Validation Master Plan (VMP)
• Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies.
• Creation and review of technical reports and documentation.
• Support or lead root cause analysis investigations for production-related or quality-related nonconformities (respectively) and develop and aid in the implementation corrective actions.
• Development and implementation of effective corrections/corrective actions.
• Partner with R&D and Manufacturing Engineers to develop/refine critical manufacturing processes.
• Function as a core-team member in cross-functional teams in the generation and implementation of improvement projects and process scale-up projects.
• Audit the manufacturing line to ensure compliance to governing procedures is being met.
• Support Internal and External (supplier) audits.
• Support elements of the Quality System such as, but not limited to, NCRs, CAPAs and Complaints.

Required Education and Experience:

• Bachelor of Science degree in engineering or relevant scientific subject required. Biomedical, biochemical or chemical degree is preferred.
• Minimum 2 years of medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company. Level I, II, III DOE.
• Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.
• Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.

Skills and Abilities Required for This Job:

• Must be able to adhere to company code of conduct and contribute to fostering a professional, collaborative and respectful team working environment.
• Ability to work effectively in a regulated manufacturing / cleanroom environment.
• Strong attention to detail while reviewing documents and records.
• Can identify work priorities and deploy resources to ensure business needs are met.
• Must be able to work effectively and collaborate within cross-functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.
• Must possess the ability to handle multiple tasks with high attention to detail.

Physical Requirements:

• Minimum traveling, less than 10%, required for tooling development and testing.
• Must be able to work in a manufacturing, laboratory, and clean room environment, including compliance with applicable gowning and PPE requirements.
• Must be able to follow clean room, laboratory, and site safety protocols at all times. 
• May require use of inspection and testing equipment as needed.