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! 

Responsibilities:

  • 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 

 

Requirements:

  • 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