IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Senior Quality Engineer - New Product Development - Irvine

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

Job Description:

Requisition ID:--1019--Job Title:--Senior Quality Engineer - New Product Development--Job Country:--United States (US)--Here at Avanos Medical, we passionately believe in three things:

  • Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
  • Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
  • Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.--At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.----Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter.--We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit .-- --The roleThe Senior Quality Engineer, NPD will provide Quality System strategic leadership and Quality Engineering responsibility associated with New Product Development including; Quality Planning, Design Control, Risk and Supplier Quality Management, Incoming / In-process Inspection and Testing, establishment of appropriate manufacturing process validation and control.-- The Senior Quality Engineer will drive a customer centric quality culture and deliver the highest quality product that consistently meets customers and regulatory requirements.--Essential Duties and Responsibilities:
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 attributesProvide leadership on Software Development Life Cycle (SDLC) Process, including software change control processes, software V&V testing, software issue tracking and defect managementProvide support as Subject Mater Expert (SME) in the application of advanced theories, concepts, principles, and processes such as, Design Control, Risk Management, SDLC Establish statistical confidence using 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 manufacturing processReview drawings to evaluate specification and requirements including correct application of geometric dimensioning and tolerancingSupports and oversees the review and approval of NC's & CAPAs related to current products and processesParticipate, Interface and support Internal and External Auditors (such as, BSI, FDA, TUV and Avanos customers).-- Prepare and track Audit Finding Reports (AFRs) in response to audit observations--Your qualifications--Required:
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, ORMaster'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 ChartsExcellent written and verbal communication skill and the capability to work and communicate in a cross-cultural environment--Preferred:
Project Management experiences or training on Project Management Certification (example: PMI Certification, Graduate Certificate in Program Management, etc.)Experience with translating IEC 60601-1 into product development requirements and evaluation of essential performance.Experience with Software Development Life Cycle (SDLC) process and hands-on Working knowledge of IEC 62304ASQ-CQE, CSQE, CQA or equivalent course work and Six Sigma Black Belt CertificationExperience with cyber security and data integrity requirements, methods and implementation-- --Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please .--Join us at Avanos
Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.--Make your career count
Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.401(k) + 6% match - immediate vesting - benefits on day 1 - uncapped sales commissions

Keywords: Avanos, Irvine , Senior Quality Engineer - New Product Development - Irvine, Other , Irvine, California

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Truck Driving Jobs - DEDICATED - Home Daily or Weekly Options & Top Pay - Colton
Description: CDL A Truck Drivers - We have high paying dedicated opportunities with daily or
Company: Marten Transport
Location: Colton
Posted on: 10/22/2019

Amazon Holiday Delivery Driver
Description: Amazon Holiday Delivery Driver br br Location: Carlsbad br We update job postings daily---opportunities for full-time delivery drivers
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/22/2019

CDL Truck Driving jobs - High Paying Dedicated - Home Weekly & Avg. 62 CPM! - Lake Elsinore
Description: Marten has a great dedicated opportunity, so you
Company: Marten Transport
Location: Lake Elsinore
Posted on: 10/22/2019


Amazon Delivery Driver
Description: Amazon Holiday Delivery Driver br br Location: Carlsbad br We update job postings daily---opportunities for full-time delivery drivers
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/22/2019

DoorDash Delivery Driver - No Experience Needed
Description: No passengers. No bosses. Just you, your tunes, and the road. Sign up now and start making money Choose your wheels and deliver food and other items from local merchants to hungry
Company: Doordash
Location: Placentia
Posted on: 10/22/2019

Driver (No HAZMAT Exp Req)
Description: Overview It's time to put your career in drive. No prior propane experience is required. We will train you Do you have experience as a Driver and hold a Class A or B Commercial Driver's License (more...)
Company: Suburban Propane
Location: Placentia
Posted on: 10/22/2019

Premier Outpatient Surgery - Collector - Colton
Description: Premier Outpatient Surgery Center specializes in Orthopedic Surgery, Spine, Pain Management, Otolaryngology, Podiatry and Plastic/Reconstruction Surgery. Our Center is one of the top multi- specialty (more...)
Company: Envision healthcare_ AMSURG Corporate
Location: Colton
Posted on: 10/22/2019

CDL Truck Driving jobs - High Paying Dedicated - Home Weekly & Avg. 62 CPM! - Placentia
Description: Marten has a great dedicated opportunity, so you
Company: Marten Transport
Location: Placentia
Posted on: 10/22/2019

Truck Driving Jobs - DEDICATED - Home Daily or Weekly Options & Top Pay - Lake Elsinore
Description: CDL A Truck Drivers - We have high paying dedicated opportunities with daily or
Company: Marten Transport
Location: Lake Elsinore
Posted on: 10/22/2019

English Educator - Work from Home
Description: iTutorGroup is the global leader in online education. We have over 20,000 teachers delivering and enjoying classes on the most versatile online learning platform. Join us and expect nothing less than (more...)
Company: iTutorGroup
Location: Yucaipa
Posted on: 10/22/2019

Log In or Create An Account

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

Irvine RSS job feeds