Senior Engineer I, Quality (Delivery System)

JENAVALVE TECHNOLOGY INC•Irvine, CA

5d•Onsite

About The Position

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.

Requirements

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.
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.

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.