Quality Engineer

We’re Willow, a team of inventors, mothers, fathers, aunties and uncles on a mission to help women live their best lives. Selected as one of TIME’s 25 Best Inventions, the Willow Wearable Breast Pump is the first all-in-one pump that fits in a bra. This is the first solution in our platform of products that re-imagines how to make women’s lives easier, healthier and fuller.

We’re always on the lookout for talented, passionate team players to help us deliver our mission. If this sounds like you, we’d love to hear from you!

General Summary: 
Responsible for supporting the implementation of the quality systems.  This role includes maintenance of the complaint system and will also support Operations and R&D.  Ensure compliance with the quality system that includes adherence with applicable international standards and regulations (e.g., FDA Quality System Regulations).  

Essential Job Functions: 

  • Participate in design reviews and create/update related deliverables
  • Create/update risk management files – hazard analyses and FMEAs
  • Support software/firmware testing
  • Write and execute validation protocols and reports
  • Maintain the complaint handling process
  • Perform complaints investigation including troubleshooting and root cause analyses
  • Responsible for complaint data trending
  • Prepare slides for periodic complaints review
  • Lead and coordinate CAPA activities including investigation, root cause analyses, corrective and preventive action plans, implementation, and effectiveness monitoring
  • Write non-conformance reports and coordinate product dispositions
  • Maintain the equipment calibration and preventive maintenance program
  • Perform receiving inspection of components
  • Review lot history records and perform product releases
  • Participate in periodic reviews of documents
  • Perform document control reviews of ECOs and support related document control activities
  • Create metrics for complaints, CAPAs, NCs, SCARs, calibration, and preventive maintenance
  • Prepare slides and participate in Management Reviews 
  • Participate in FDA and other regulatory agency audits 
  • Perform internal audits
  • Conduct supplier audits and other supplier quality activities including maintenance of the ASL
  • Maintain Quality System logs

Education/Training/Experience/Skill Requirements: 

  • 4+ years of Quality Assurance experience in the medical device industry
  • Bachelor’s degree in engineering preferred
  • Thorough knowledge of FDA QSR, ISO 13485, MDD requirements
  • Experience in internal and external audits
  • Knowledge of design control requirements and necessary activities
  • Able to support development of products from initial concept to commercial product
  • Must have computer skills and experience working with spreadsheets, word processors, and database programs
  • Demonstrated problem-solving capabilities and skills in statistical analysis
  • Attention to detail, good organization skills, ability to work under pressure
  • Good communications and interpersonal skills, ability to multitask, self-starter, resourceful, willing to learn and take on new tasks as assigned

Submit your cover letter & resume