Senior Engineer I, Quality (Delivery System)

Job Title:

Senior Engineer, Quality (Delivery System)

• Senior Engineer I, Quality ( Delivery System)
• Senior Engineer II, Quality ( Delivery System)
• Senior Engineer III, Quality ( Delivery System)

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 Quality Engineering support to delivery device manufacturing in various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment.

Job Responsibilities:

• Partner with Manufacturing Engineers to develop, 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 products are produced in a compliant manner and ensure all manufacturing records received are reviewed, approved, and filed in compliance with QSRs and ISO standards.
• 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.
• Lead cross-functional teams in the creation and development of risk management documents, Process FMEA and others as required by JenaValve internal procedures.
• Lead cross-functional teams in the generation and implementation of improvement projects and process scale-up projects.
• Audit the manufacturing line to ensure compliance with governing procedures is being met.
• Support Internal and External (supplier) audits.
• Maintain applicable equipment, including preventative maintenance and calibration, in line with the relevant SOPs.
• Support or lead root cause analysis investigations for production-related or quality-related nonconformities (respectively) and develop and aid in the implementation corrective actions.
• Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related activities.
• Support elements of the Quality System such as, but not limited to, NCRs, CAPAs and Complaints.

Qualifications

Required Education and Experience:

• Bachelor of Science degree in engineering or relevant scientific subject required.
• 4 + years 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.
• 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 have strong project management and documentation skills.
• Must take initiative and can conduct hands-on work.
• Must possess the ability to handle multiple tasks with high attention to detail.

Physical Requirements:

• Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.
• 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 rooms, laboratory, and site safety protocols at all times.
• May require use of inspection and testing equipment as part of routine job duties