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Job

Sr. Quality Engineer (#2549)

  • Job ref:

    9253

  • Location:

    Southborough, United States

  • Sector:

    Quality Engineers

  • Job type:

    Contract

  • Contact:

    Lissa Jerez

  • Published:

    5 months ago

  • Consultant:

    #

Responsibilities: 
 

  • Cross-Functional Team member to support, procurement, manufacturing and servicing processes representing Supplier Quality Engineering discipline  
  • Completes assigned Supplier Quality Engineering tasks to schedule
  • Promotes awareness of Quality and Regulatory requirements
  • Applies statistical process control (SPC) methods to evaluate current processes and process changes
  • Develops new approaches to solve problems identified as part of the team  
  • Applies the requirements of the Quality System to processes, products or services for multiple remote locations
  • Supports the manufacturing line to address quality issues and resolution
  • Using Non-conforming material reports(NCR) and/or supplier corrective action requests(SCAR)
  • Supports validation and verification strategy for changes to existing products and processes as assigned
  • Participates in the CAPA process as required as an assignee or project team member  
  • Investigates escalated product complaints to root cause to ensure timely customer response and correction
  • Participates MRB as a team member to ensure proper disposition of non-conformances
  • Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
  • Conducts internal, vendor, and process audits to schedule  
  • Interfaces with suppliers to resolve Quality issues  
  • Develops and drives measurable Quality improvements relating to products, processes and services

 

Qualifications:
 

  • Bachelor’s degree in Engineering discipline or equivalent  
  • Eight plus year’s related experience and/or training; preferably in the medical device industry related to process/quality engineering
  • Leadership experience; ability to lead and manage cross-functional teams  
  • Knowledge of basic mechanical testing and material properties  
  • Knowledge of metrology
  • Working knowledge of problem-solving skills, good statistical and analytical skills
  • Working knowledge of Problem-Solving Tools
  • Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistic)
  • Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to management
  • Proficient in the use of Information Technology and applications