Balt · 13 hours ago
Quality Engineer II
Irvine, CA
Full-time
Onsite
Entry, Mid Level
$85K/yr - $95K/yr
2+ years expBalt is a rapidly growing pioneer in the field of medical devices, dedicated to improving the lives of patients. The Quality Engineer II will support production quality and supplier quality activities, working closely with production teams to enhance manufacturing processes for neurovascular medical devices.
Health CareManufacturingMedical Device
Responsibilities
Production support of existing products/processes and sustaining work
Support the manufacturing organization to facilitate efficient operations, optimize existing processes, and ensure that production goals are met
Develop process and procedure updates for increased efficiency, quality, and productivity
Work with Manufacturing Engineering to correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions
Own NCMR and CAPA investigations and corrections/corrective actions
Support requests for new supplier onboarding and offboarding
Complete tasks related to supplier changes and management of existing suppliers
Spend significant portions of time in the production environment
Work closely with production operators and Quality Control inspectors in the production environment
Provide feedback to Quality, Operations, Engineering and R&D on quality issues
Detail oriented review and approval documentation in support of production and process improvement
Development project work – design transfer, commercialization of new products, and site manufacturing transfers
Interface with New Product Development team in design control projects to integrate new products or processes into the existing manufacturing area
Process development, validation and verification work is required – knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation/gage R&R, a clear understanding of FDA’s QMSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement
Communicate with suppliers to address quality concerns and resolves issues
Maintain and develop processes and procedures by writing standard work instructions for operations involved with production and quality
Qualification
Required
Bachelor's degree required, preferably in engineering or science discipline
2+ years as an Engineer in a related field
Medical device or pharmaceutical experience
Process and Equipment qualification knowledge
Statistical analysis skill set
Keen attention to detail when reviewing documentation and processes
Solid technical writing ability
Comfortable working independently and cross-functionally as part of a team
Comfortable communicating with a wide range of people (production, regulatory, management, suppliers, and others)
General understanding of Risk Management, including design, use, and process FMEAs as well as a basic understanding of Severity, Occurrence, and Risk Mitigation and their impact on product/process controls
General understanding of Process Validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices
General understanding of CAPA process and root cause analysis tools and how to use them
Ability to develop/draft manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders)
General familiarity with design control requirements and V&V testing for new product designs
Effectiveness with lab equipment, assembly tools, and measurement devices
Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing
Development and qualification of tooling/ equipment (IQ/OQ, support, design)
Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required
Preferred
Class II and III implantable medical device experience with focus on neurovascular devices
Experience creating and implementing new production line layouts
Minitab proficiency
Strong background in medical device components using metals, plastics, extrusion, and/or adhesives
A demonstrated ability to plan and run projects
Experience with catheters, coils, or stents device manufacturing processes and equipment
Test Method Validation and/or Measurement System Analysis experience, including Gage R&Rs and Attribute Agreement analysis
Process background (development, capability, optimization, validation) within the medical device industry
Equipment and tooling design and optimization using DFM and Six Sigma principles
Leading project teams tasked with new product/process development and the successful transfer into manufacturing
Knowledge to develop and improve manufacturing processes from concept to commercialization including characterization, validation and cost/capacity analysis
Application of statistical and analytical methods for process development, optimization and control such as SPC, SQC, and DOE
Knowledge of SolidWorks for both part and fixturing/equipment design
Company
Balt
Balt is specialist manufacturer of 'Interventional Neuro Radiology’ (‘INR’) devices used to treat strokes and aneurysms
501-1000 employees
H1B Sponsorship
Balt has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
Funding
Current Stage
Late StageTotal Funding
$370.32M2024-12-20Debt Financing· $370.32M
2015-09-25Private Equity
2015-09-25Acquired
Leadership Team
Pascal Girin
CEO
Emeric Domergue
Deputy CFO
Company data provided by crunchbase