IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Senior Quality Engineer, New Product Development

Company: Talent
Location: Irvine
Posted on: October 12, 2019

Job Description:

We have a unique opportunity for you to work with an incredible medical technology company that is committed to creating the next generation of innovative healthcare solutions.

We're in search of a Senior Quality Engineer, New Product Development, one who will provide Quality System strategic leadership and Quality Engineering responsibility associated with New Product Development.
What you'll be doing:
Provide Quality Engineering duties related to New Product Development Process and Design Control, such as VOC Translation, Quality Planning, Human Factor Engineering, Supplier Quality Management, Manufacturing Process Validation, and Process Control Develop Risk Management Files including Hazard Analysis, FMEAs [Use, Design, and Process]. Lead identification of potential risks, failure modes, and risk controls measures Ensure documented evidence exists to demonstrate a high degree of assurance that the product meets requirements, specifications and critical to quality attributes Provide leadership on Software Development Life Cycle (SDLC) Process, including software change control processes, software V&V testing, software issue tracking, and defect management Provide support as Subject Matter Expert (SME) in the application of advanced theories, concepts, principles, and processes such as Design Control, Risk Management, SDLC Establish statistical confidence using a valid sample size and acceptance criteria. Utilize advanced quality engineering tools (such as DMAIC, DMADV or DFSS, DOE, etc.) Lead complex complaints, deviations or failures investigations. Apply systematic problem-solving methodologies to identify, prioritize and resolve quality issues Understand and apply the manufacturing process tools including IQ/OQ/PQ, GR&R, Process and Control and Validation Plans and Protocol, Data Analysis (Cpk, Cp, SPC), identify items Critical to Quality (CTQs) and cascading to the manufacturing process What we are looking for: B.S. degree in Mechanical or Electrical, Computer or Biomedical Engineering or equivalent technical discipline with Minimum of 5 years Quality Engineering experience in a Medical Device or Regulated Industry and working knowledge of 21 CFR Part 820 & ISO 13485, OR
Master's degree in Mechanical, Electrical, Computer or Biomedical Engineering or equivalent technical discipline with Minimum of 3 years Quality Engineering experience in a Medical Device or Regulated Industry and working knowledge of 21 CFR Part 820 & ISO 13485 In-depth knowledge of New Product Development (NPD) process and Design Control requirements (design verification and validation, test method development, Design Traceability Matrix, and Design History File construction) Thorough knowledge of IEC 62366 and ISO 14971 Risk Management System, such as, of Hazard Analysis, FMEAs [Use, Design, and Process] Working knowledge of Statistical Analysis Tools (such as, Minitab, SPC, JMP) and Six Sigma concepts and practices (DMAIC, DMADV, DFSS or DOE) Leadership ability in using problem-solving investigational technical tools, such as Cause and Effect Analysis Diagrams, Process Optimization, Trend and Capability Analysis, and various Control Charts ***Bonus Points for*** Project Management experiences or training on Project Management Certification Experience with translating IEC 60601-1 into product development requirements and evaluation of essential performance. ASQ-CQE, CSQE, CQA or equivalent course work and Six Sigma Black Belt Certification
What's in it for you: 401(k) + 6% match - Immediate Vesting - Benefits on Day 1 - Uncapped Sales Commissions

Ready to jump in? Send your resume over today or request a time to chat more with our recruitment team. We can't wait to meet you!
Please note: we only consider applicants with the current legal right to work in the countries in which our positions are based. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, sexual orientation, age, disability, marital status or gender identity.

Keywords: Talent, Irvine , Senior Quality Engineer, New Product Development, Engineering , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


to $16/hour! **QC Inspector - electronics/lighting
Description: FANTASTIC opportunity for an entry-level QC Inspector. Join this successful high-end
Company:
Location: Anaheim
Posted on: 10/18/2019

Senior Electric Mechanical Maintenance Technician - Full Time Hours
Description: This Senior Electric Mechanical Maintenance Technician Position Features: br Full Time Hours br Stable Company br Full Benefits br Great
Company:
Location: Sylmar
Posted on: 10/18/2019

Senior Electrical Mechanical Maintenance Technician
Description: This Senior Electrical Mechanical Maintenance Technician Position Features: br Great Pay to 82K in a stable, family oriented work environment br br Immediate need for a Senior Electrical Mechanical (more...)
Company:
Location: Sylmar
Posted on: 10/18/2019


Rebar Estimator
Description: This Rebar Estimator br Great Pay to 65K br br Immediate need for rebar estimator br br Software used: Auto CAD br br Main Duties: br 1 Knowledge of REBAR
Company:
Location: Corona
Posted on: 10/18/2019

Junior Engineer/Tech -
Description: Must come from a MANUFACTURING BACKGROUND br br BASIC FUNCTION - Setup machines, continuous improvement of existing machines, new machine design and development, and maintains production and (more...)
Company:
Location: Camarillo
Posted on: 10/18/2019

46871-4812 - Manufacturing Engineer
Description: Requisition : 46871-4812 br / Positions : 3 br / Start Date : 1/19/2015 br / End Date : 7/31/2015 br / Over Time Allowed : Yes br / Interview Type : Interview br / Travel : No Travel Required (more...)
Company:
Location: Santa Ana
Posted on: 10/18/2019

Sr Engineer
Description: Lead or support teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, (more...)
Company:
Location: Newbury Park
Posted on: 10/18/2019

PROJECT MANAGER 3 - NEEDED ASAP DOWNTOWN!!
Description: Immediate long term asignment for a Project Manager 3 in Downtown Los Angeles br br Qualifications: br Bachelor s degree or equivalent experience, preferably in a business or technical field. (more...)
Company:
Location: Los Angeles
Posted on: 10/18/2019

PROJECT MANAGER 3 - NEEDED ASAP DOWNTOWN!!
Description: Immediate long term assignment for a Project Manager 3 in Downtown Los Angeles br br Qualifications: br Bachelor s degree or equivalent experience, preferably in a business or technical field. (more...)
Company:
Location: Los Angeles
Posted on: 10/18/2019

$75000 Mechanical Engineer -
Description: North Orange County Manufacture of Commercial Appliances is seeking to add a Mechanical Engineer to their team to work on new product development. br br You will be responsible for designing from (more...)
Company:
Location: Cypress
Posted on: 10/18/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds