More jobs:
Senior Engineer , Quality; Delivery System
Job in
Irvine, Orange County, California, 92618, USA
Listed on 2026-06-01
Listing for:
JenaValve
Full Time
position Listed on 2026-06-01
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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)
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.
- 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 Jena Valve 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.
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 21
CFR
820, ISO 13485, and ISO
14971 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.
- 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
Position Requirements
10+ Years
work experience
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