Quality Engineer II

BALT Group•Irvine, CA

2d•$85,000 - $95,000

About The Position

About this opportunity – Quality Engineer II Description The Operations Quality Engineer II will be responsible for supporting production quality, the transfer of neurovascular products to the production environment, and supplier quality activities. This engineer will be expected to work directly with production and suppliers while being provided moderate levels of support/guidance from other engineers and their manager to complete tasks. This position will have the responsibility to support and continuously improve current manufacturing and supplier quality processes through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Requirements

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.
Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.

Nice To Haves

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.

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.
Development and qualification of tooling/ equipment (IQ/OQ, support, design).