NeuroVasc is seeking a SENIOR QUALITY ENGINEER to join our team in Irvine!
What we’re looking for:
Collaborative partners who play well with others, interdepartmental and cross functional, team members who are NOT quick to jump to conclusions. Those who give others the benefit of the doubt while they gather all the facts.
Active Listeners who build relationships and unite team members, those who seek resolution at all costs. Team members who work together, sharing ideas and driving continuous improvement in all areas.
Problem solvers who go beyond identifying and fixing the problem, team members who look for ways to prevent future issues by identifying the root cause and seeking to improve current solutions.
Dedicated Doers, who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Inspired innovators, who are passionate about researching, developing, and executing.
Strategic thinkers, team members who continually look for opportunities to make things better, processes and beyond.
Detailed documenters, people who understand the end game, of positive patient outcomes. Everything we do is to better our patient’s quality of life. Every plan and report.
Accountable Initiators who take ownership of their work (errors too), persistently striving for resolution. Team members who drive productivity and positive change.
What you’ll do:
Reporting to the Sr. QA/RA Manager, our Sr. Quality Engineer will be responsible for creating and implementing a safety program that ensures employee safety and enables company compliance. Responsible for maintaining the NCMR, CAPA, Document Control, Complaints, and Supplier Quality systems. Responsible for developing and qualifying quality procedures, including test and inspection methods for medical device development and manufacturing. Supports compliance to regulatory requirements, while creating, monitoring, and supporting inspections, assembly, and testing for medical device qualification and manufacturing by performing the following duties.
Creates and implements a safety program that ensures employee safety, enables company compliance, and scales with company growth.
Creates and/or reviews quality documents including protocols, reports, test methods, inspection methods, design dossier, submissions, and procedures.*
Performs and documents risk management activities.*
Creates design documents including drawings, specifications, protocols, reports, and procedures.
Supports regulatory submissions, notifications and registrations*
Supports preventative maintenance system and compliance
Creates and implements systems and procedures to ensure a safe work environment for working with chemicals, hazardous materials, and various equipment and tools. Safety programs include*:
Access to Employee Exposure and Medical Records
Accident Investigation and Reporting, Back Safety in the Workplace
Bio-Medical Waste Management
CA IIPP Safety Management
Evacuation and Fire Prevention
Ergonomics and MSD
Eye Wash Station and Safety Shower
General Safety Awareness, Hand and Portable Power Tools,
Personal Protective Equipment
Walking and Working Surfaces
Researches, reviews, and interprets standards and regulations to determine statutory obligations.*
Creates and implements systems to ensure compliance with state and federal statutory safety requirements.*
Designs safety systems, programs, documentation, and records to interface efficiently with Quality System requirements.*
Works with and supports the complaint, MDR, Vigilance, and Problem Reporting systems.*
Performs returned unit investigation.*
Nonconformance and CAPA systems
Manages the NCMR and CAR systems.*
Works in and supports the CAPA system.*
Performs root cause investigation, corrective actions, material disposition, scoping, and containment.*
Determines and reviews documentation and practices for compliance to applicable standards and current best practices.*
Improves systems for design, development, qualification, calibration, maintenance, and manufacturing.*
Assists in quality and regulatory system creation and implementation.*
Supports quality and compliance aspects of inspection and test facilities, operations and maintenance.*
Test Methods and Equipment
Develops, qualifies and reviews test and inspection methods, including inspection and test equipment qualification.*
Creates, validates, and releases test methods, including sourcing equipment for measurements.*
Creates test models for development and qualification of devices.*
Creates calibration and inspection procedures, executes, and documents procedures.*
Supervises and performs testing, including pre-clinical testing such as in vivo testing.*
Defines and coordinates testing with outside test laboratories, including pre-clinical test labs.*
Utilizes statistical methods to analyze test data and make conclusions regarding the safety and efficacy of product.*
Plans subprojects, communicates plans, tracks and communicates progress, maintains accountability, and provides updates to management and the team.*
Identifies, collaborates with, and qualifies vendors for device components and supplies.*
Performs supplier audits.*
Supports receiving inspection.*
Creates and reviews First Article Inspection plans and results.*
Assists in prototyping and developing medical devices.*
Determines usability requirements and test methodology, creates protocols, reports, and files as needed.*
Assists in determining user needs.
Works with users to optimize device behavior and usage methodology.
Assists with design and development of medical devices from concept through commercialization.
Develops and qualifies processes and manufacturing procedures, including equipment qualification.*
Designs, creates, sources, builds, calibrates, qualifies, and maintains equipment used to manufacture and prototype devices.
Performs investigation and makes quality decisions on product.*
Reviews visual and dimensional anomalies and creates visual standards.*
Facilitates production by creating work orders, printing IFUs, labeling, and performing inspections and LHR reviews as necessary.
Performs device assembly and testing as necessary.
Component inventory planning and ordering as necessary.
Supports quality aspects of field inventory management.*
Supports users and clinical work in the field.
Assists in clinical protocol development
Performs clinical site audits
Supports compliance of clinical investigations to protocols, standards, and good clinical practice.
What you need:
Bachelor’s degree (B.S.) from four-year college or university in engineering or technical field; and four to twenty years related experience and/or training; or equivalent combination of education and experience.
Four years’ experience in medical device manufacturing quality preferred.
Knowledge of Microsoft Word, Microsoft Excel, internet software, computer aided design (CAD) software, Statistics software, and Quality systems software.
Oral and written communication skills
Time management skills
Ability to interface with customers in highly technical fields
NeuroVasc is an equal opportunity employer.