Innovation Excellence Quality Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

This role is for an Innovation Excellence Quality Engineer in the MedTech sector, focusing on Design Quality Engineering functions for continuous improvement and innovation of marketed products. Responsibilities include risk management, design verification, design validation, design assurance, manufacturing process support, statistical analysis, and ensuring compliance with regulatory requirements like FDA QMSRs and ISO 13485. The role supports Abiomed's single-use heart pumps and requires a Bachelor's degree in Engineering or Sciences with 0-2 years of quality experience, preferably in the medical device industry.

What you'd actually do

  1. Support Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting.
  2. Navigate existing FMEA’s and Hazard Analysis in support of sustaining and lifecycle activities.
  3. Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments.
  4. Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
  5. Review and approve Engineering Change Requests (CR’s) and support the Non-Conformance (NC’s) process as necessary.

Skills

Required

  • Bachelor degree in Engineering or Sciences
  • 0 - 2 years of quality experience
  • Demonstrates knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
  • Takes initiative and works well in a team environment

Nice to have

  • Masters degree
  • Experience in the medical device industry
  • cardiovascular devices experience

What the JD emphasized

  • FDA and other regulatory knowledge and experience is applied to risk and testing assessments
  • FDA QMSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard