-
Quality Engineering Manager
1 week ago
Eaton Irvine, United StatesEaton's IS AER FMC division is currently seeking a Quality Engineering Manager. This position will be a part of Eaton's Aerospace group, specifically supporting the Irvine California facility. This facility has roughly 200 employees, with output in excess of $100M annually. · The ...
-
Quality Engineer
2 weeks ago
Sanmina Costa Mesa, United StatesThe Quality Engineer will play a key role in the Quality organization of the team that makes some of the most complex and mission critical PC - Bs solutions on the planet. The Quality Engineer will work closely with the Quality Assurance and Operatio Quality Engineer, Engineer, Q ...
-
Quality Engineer
2 weeks ago
Sanmina SCI Costa Mesa, United StatesCategory (For Job Seekers) · Quality · Location · H4021 - Viking Technology - Costa Mesa, CA 92626 US · US (Primary) · Job Description · Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global ...
-
Quality Engineer
2 weeks ago
Anduril Industries Costa Mesa, United StatesAs a Quality Engineer, you will work inside and outside the organization to define and execute processes that deliver reliable products. This role focuses on Group 5 products and the avionics sub-systems - flight controls, navigation, communication, ground proximity warning syste ...
-
Quality Engineer
1 week ago
Sanmina-SCI Costa Mesa, United StatesSanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing ...
-
Quality Engineer
2 weeks ago
Sanmina-SCI Costa Mesa, United StatesSanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing ...
-
Quality Engineer
2 weeks ago
Titan Ventures West Park, United StatesYour roles and responsibilities · Quality assurance for multiple production processes · Quality pre-planning · Independent preparation and support of customer audits · Handling of complaints internally and externally · Workshop support · Moderation of process FMEA · Planning and ...
-
Quality Engineer
1 week ago
Sanmina Costa Mesa, United StatesShare this job as a link in your status update to LinkedIn. · Category (For Job Seekers) · Quality · Location · H4021 - Viking Technology - Costa Mesa, CA 92626 US · US (Primary) · Job Description · Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutio ...
-
Manager - Quality and Engineering
2 weeks ago
The Timken Company Los Alamitos, United StatesPersonal and Professional Growth · Manager - Quality and Engineering · - Los Alamitos, CA, US, Your Career Begins at Timken · - If you're ready for a challenging career that provides you with the ability to advance personally and professionally, look to Timken. Our associates mak ...
-
Senior Quality Engineer
2 days ago
Macom Technology Solutions Holdings, Inc. Newport Beach, United StatesCompany Overview: · MACOM designs and manufactures semiconductor products for DataCenter, Telecommunication and Industrial and Defense applications.Headquartered in Lowell, Massachusetts, MACOM has design centers and salesoffices throughout North America, Europe and Asia. MACOM ...
-
Quality Engineer II
3 weeks ago
Renata Medical Newport Beach, United StatesQuality Engineer II · Renata Medical · Newport Beach, CA · From $78,000 a year · Full-time · Position Overview · Renata Medical is seeking an experienced quality engineer to develop critical functions for commercial pediatric cardiovascular medical devices. The role involve ...
-
Quality Assurance Engineer
1 week ago
Pacific Life Newport Beach, United StatesJob Description · Join us as a trailblazing Quality Assurance (QA) Automation Engineer in the Workforce Benefits Insurance domain, where your expertise will be the driving force behind our mission to revolutionize the insurance landscape through cutting-edge digital solutions. A ...
-
Quality Systems Engineer
2 weeks ago
Cathworks Newport Beach, United StatesJob Description · Job Description Salary: · CathWorks, with offices in Israel, USA, Japan, and the Netherlands, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio System combines artific ...
-
Product Quality Engineer
2 weeks ago
Anduril Industries Costa Mesa, United StatesAnduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...
-
Product Quality Engineer
2 days ago
Anduril Industries Costa Mesa, United StatesAnduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...
-
Quality Systems Engineer
6 days ago
BlueWing Ventures, LLC. Costa Mesa, United StatesAnduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...
-
Quality Engineer
1 day ago
Pathway Group Huntington Beach, United StatesJob Description · Job DescriptionQUALITY ENGINEER · JOB SUMMARY · The Quality Engineer is responsible for monitoring the performance of customer and internal KPI. This role champions improvements using analysis and implements corrections and improvements using quality tools such ...
-
Engineering & Quality Assurance Supervisor
2 weeks ago
Camisasca Automotive Manufacturing Lake Forest, United States**ABOUT US**: · - This is your opportunity to work with the finest automobile manufacturers in the world Come join our team of professionals in an established yet contemporary, family owned & operated company with 40 years' experience in quality parts manufacturing and global dis ...
-
Quality Engineer
1 week ago
Essex Industries Huntington Beach, United StatesEssex Industries is a fast-growing CNC machining operation located in Huntington Beach, CA. We provide high quality parts, assemblies and devices to the Aerospace and Medical market sectors. Our industries require impeccable quality and we are seekin Quality Engineer, Engineer, I ...
-
Quality Engineer
3 days ago
ESSEX INDUSTRIES INC AND Huntington Beach, United StatesJob Description · Job Description Description: Essex Industries is a fast-growing CNC machining operation located in Huntington Beach, CA. We provide high quality parts, assemblies and devices to the Aerospace and Medical market sectors. Our industries require impeccable quality ...
Quality Engineer II - Newport Beach, United States - Renata Medical
Description
Quality Engineer IIRenata Medical
Newport Beach, CA
From $78,000 a year
Full-time
Position Overview
Renata Medical is seeking an experienced quality engineer to develop critical functions for commercial pediatric cardiovascular medical devices. The role involves managing a diverse range of responsibilities related to implementation and maintenance of the quality management system.
This candidate will report directly to the Director of Quality and will play a pivotal role in developing new devices in the pediatric cardiology space and ensure the safety and efficacy of those devices.
Renata is a fast-paced startup company that will rely on a motivated candidate able to work with a small team, embrace new challenges, and develop a strong quality system to support development and commercial goals.
Quality ActivitiesResponsible for developing test methods and documenting protocols/reports to verify and validate device design, process, sterilization, shelf-life, biocompatibility, distribution, and others.
Responsible for investigating CAPAs, SCARs, Product Complaints, Non-Conforming Material Reports, RGA's and other QA processes and identifying and implementing effective corrective and preventive actions.
Performs trend analysis and establishes corrective/preventive actions as required.Responsible for set-up and validation of test methods, procedures and sampling plans for inspection and testing of finished products.
Responsible for conducting hazard analysis and ensuring design and process FMEAs are conducted per ISO 14971.
Responsible for initiation and approval of change orders (COs) with proper documentation of change, reasons and justifications.
Responsible for monitoring supplier quality.
Assists in supplier audits to ensure continued compliance and acceptability.
Performs statistical analysis of product testing data.
Performs robust root cause and corrective action analysis.
Performs internal audits per the audit plan and implement/assist in implementing corrective and preventive actions.
Recommends improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
Follows and enforces compliance to the Company's quality system and regulatory body requirements per ISO 13485/FDA's QSRs.Responsible for providing support to achieve quality objectives.
Completes projects in a timely manner and consistent with corporate objectives.
Identifies needs and document SOPs, test methods, protocols, reports, DCOs, etc.
Interfaces with suppliers, contract manufacturers, contract developers.
Ensures proper documentation of Design History Files per the company's procedures.
Position Requirements
Prior experience in the medical device field
Proficient in use of MS Word, Excel, and PowerPoint
Ability to read and understand industry standards and regulations
Ability to perform basic statistics and willingness to learn more advanced statistical methods
Education Requirements
Bachelor's degree for engineering or comparable experience
Experience Requirements
2+ years quality engineering/assurance experience with medical devices
High level of organizational skills
Basic statistical skills
Benefits
Health insurance
Dental insurance
Paid time off
Stock options
Bonus pay
#J-18808-Ljbffr