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 www.avanos.com . The role The 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 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 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 process Review drawings to evaluate specification and requirements including correct application of geometric dimensioning and tolerancing Supports and oversees the review and approval of NC’s & CAPAs related to current products and processes Participate, 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, 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 Excellent 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 62304 ASQ-CQE, CSQE, CQA or equivalent course work and Six Sigma Black Belt Certification Experience 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 apply here . 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


DoorDash Delivery Driver - No Experience Needed - Placentia
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
Company: Doordash
Location: Placentia
Posted on: 10/18/2019

Admin Assistant - Marriott Hotels (150001JW)
Description: It s a powerful feeling, to belong. It s inspiring people to do more than they thought they could. It s leading the way by rolling up your sleeves to accomplish a common goal. It s taking a passion and (more...)
Company:
Location: Palm Desert
Posted on: 10/18/2019

Roofing/Construction Supervisor
Description: CASTRO ROOFING, INC. IS SEEKING A FULL-TIMERoofing/Construction Supervisor PALM DESERT, CA 25.00 an hour - Salary weekly paycheck. MUST HAVE CONSTRUCTION OR ROOFING
Company: Castro Roofing
Location: Palm Desert
Posted on: 10/18/2019


Sterile Processing Tech Full Time Evening
Description: Shift 12:00 pm - 8:30 pm br Since 1972, Placentia-Linda Hospital has expanded right along with north Orange County. As our communities grow, we continue to offer a full range of medical services to (more...)
Company: Tenet
Location: Placentia
Posted on: 10/18/2019

Regional CDL A Truck Drivers - $5,000 Sign On Bonus!
Description: REQUIRED QUALIFICATIONS AND EXPERIENCE: Minimum age of 21 CDL A License Required Minimum of 1 years verifiable driving experience No convictions for driving under the influence in the last 5 years (more...)
Company: Gourmet Foods International
Location: Yucaipa
Posted on: 10/18/2019

Attd-Gourmet Coffee-Barista - JW Marriott Desert Springs Resort & Spa (150001HK)
Description: It s a powerful feeling, to belong. It s inspiring people to do more than they thought they could. It s leading the way by rolling up your sleeves to accomplish a common goal. It s taking a passion and (more...)
Company:
Location: Palm Desert
Posted on: 10/18/2019

Guest Service Representative - JW Marriott Desert Springs Resort & Spa (14001Z3J)
Description: It s a powerful feeling, to belong. It s inspiring people to do more than they thought they could. It s leading the way by rolling up your sleeves to accomplish a common goal. It s taking a passion and (more...)
Company:
Location: Palm Desert
Posted on: 10/18/2019

Admin Assistant - Marriott Hotels (150001UO)
Description: It s a powerful feeling, to belong. It s inspiring people to do more than they thought they could. It s leading the way by rolling up your sleeves to accomplish a common goal. It s taking a passion and (more...)
Company:
Location: Palm Desert
Posted on: 10/18/2019

General Labor
Description: Title: Warehouse ndash Production Operators br br Adecco is assisting a local client recruiting for a current Warehouse ndash Production Operators job in Ontario. This is a long-term temporary (more...)
Company:
Location: Colton
Posted on: 10/18/2019

Outside Sales Representative
Description: At A Glance li Full-time sales role good for students, grads, and people who appreciate flexibility, with potential for advancement and no ceiling on commission bonuses. li A role that is ideal for (more...)
Company: Spectrum
Location: Placentia
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