Quality Engineer - Complaint Handling

Willow

Mountain View, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 05/13/2021
  • Website: shop.willowpump.com
  • Company Address: 1975 W. El Camino Real, Suite 306, Mountain View, CA, 94040

About Willow

We’re Willow, a team of inventors, mothers, fathers, aunties and uncles on a mission to help women live their best lives starting with the Willow Wearable Breast Pump.

Job Description

Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow Wearable Breast Pump is the first solution in our platform, but we have more to come. Willow is a complete re-imagining of the breast pump - it is the first all-in-one breast pump that fits in a bra. Willow is mobile, discreet and gives moms their hands back. Willow cuts the cords and banishes dangling baby bottles so busy multi-tasking moms can pump wherever the day takes them. Willow is a smart, connected device that tracks moms’ milk volume in real time and delivers all of her past pumping sessions to the palm of her hand. Willow is a whole new pumping experience, and it is changing the lives of women everywhere.

 

Selected as one of TIME's 25 Best Inventions in 2017, the Willow Wearable Breast Pump was also distinguished with the 2018 CES Innovation Award for Wearable Technologies.

 

Job Overview:

Willow is looking for a Quality Engineer who will be responsible for the management of product complaint handling program.  This role will report to the Senior Manager of Quality. This person will lead complaint investigation, develop and maintain complaint metrics, and conduct data analyses.  The Quality Engineer will support sustaining engineering projects through assessment and identification of product issues for product improvements and other QMS activities related to commercial products.  This role will ensure compliance with the quality system that includes adherence with applicable regulations and international standards.

 

 

What you'll do:

Main Role:

  • Oversee the complaint handling program by managing day to day activities and interfacing with Customer Care, R&D, and Operations Departments
  • Conduct complaint investigation and perform data analyses
  • Develop and maintain product complaint metrics

 

Support Other Quality System Elements:

  • CAPA and NC
  • Calibration and preventive maintenance
  • Receiving inspection
  • Product release
  • ECO reviews
  • Quality metrics
  • Training program
  • Regulatory agency and notified body audits
  • Internal audits
  • Supplier audits, supplier evaluations, and ASL

 

What you'll bring:

  • 5+ years of combined QA/QE experience in medical device industry
  • Experience working with electro-mechanical devices, preferably in high volume manufacturing
  • Experience working in a medical device start-up environment a plus
  • Bachelor’s degree in engineering, preferably mechanical
  • Working knowledge of FDA QSR, MDSAP, and ISO 13485 requirements
  • Experience in internal and external audits
  • Knowledgeable of design control requirements
  • Detail-oriented, good organizational skills, and ability to multitask
  • Ability to work effectively and independently under minimal supervision
  • Good communications and interpersonal skills, ability to work collaboratively with cross functional team members

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.