Sr. Manufacturing Quality Engineer

Practice Area bioscience
Job Family Quality Control
Job Type Perm Salary
Location Northeastern MA

Do you work well independently and as part of a team? Do you have exceptional organizational skills as well as strong communication abilities? If so, this Sr. Manufacturing Quality Engineer position is great fit for you. Submit your resume to apply today! 


  • Work in compliance with manufacturing steps applicable to quality system guidelines
  • Coordinate with manufacturing engineer to make sure the required process controls and validations are in effect and the appropriate practices are followed
  • Assist with the implementation and development of production monitoring procedures and systems for testing and inspecting products
  • Help manage measurement system analysis activities  
  • Approve manufacturing processes such as equipment installation qualification, operational qualification, and performance qualification
  • Administer guidance on corrective and preventative actions by tracking production information in support of risk management
  • Establish process optimization with DOE and retrospective data analysis to comprehend and decrease process variation sources that are affecting products
  • Support quality engineering for developing and manufacturing disposable medical devices
  • Track and report manufacturing trends, complaint trends, MRR trends, and other quality system metrics
  • Give written and verbal reports on activities and results for the supervisors/managers
  • Guide decision making using probability concepts and statistical quality control
  • Act as Quality liaison during product improvement meetings associating with supplier requirements
  • Meet production demand by resolving all quality issues
  • Direct “Quality at the Source” program to increase yields and qualifying quality inspections at the supplier facility
  • Make sure audit schedule is accurate and adhered to
  • Qualify new suppliers and identify technical tests/documentations needed
  • Manage ASL and supporting documents needed per SOPs 



  • Engineering degree or related degree
  • 5 or more years of QA/QE experience in the medical device field
  • Working knowledge of manufacturing complex products in an ECA
  • Experience in manufacturing quality control
  • Formal problem-solving methods and deductive skills
  • Strong understanding of FDA QSRs, ISO3485, Ordinance 169, ISO14971
  • Background working with non-conforming materials such as root cause investigations regarding non-conformities
  • Production equipment and production process experience
  • Experience performing internal audits
  • SAP or different ERP system experience preferred



Position ID: 38172