Sr. Principal Quality Engineer

2 days ago

Warsaw, United States Planet Pharma Full time

The role of this Quality / Process Eng is to stablish the process control needed for the manufacturing process of company products.

This role works closely with CNC programmers to stablish the control method to satisfy the print and process requirements

To be able to perform this tasks the candidate shall have the capability of reading blue prints for which a deep understanding of GD&T is required

Also to be able to develop inspection systems with capability of satisfying print requirements and set up SPC to control the process based on historical data

Top 3 technical skills that are required for the role:

  1. SPC
  2. GD&T
  3. Measurement Systems development
  4. Process control

Education Required:

Bachelors Degree in an Engineering Discipline and at least 4 years of relevant experience or proven records of a high tech manufacturing environment providing direct manufacturing process support Or

Masters Degree in an Engineering Discipline and at least 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support.


Years’ Experience Required:

More than 10


TECHNICAL SKILLS

Must Have

  • 1. Medical device process development and manufacturing, experience of products with electrical functionality an advantage
  • 2. Examples of critical thinking and use of statistics
  • 3. Working in a cross functional teams and leveraging basic PM skills e.g. project planning, communication, risk management, etc.
  • Work collaboratively and with respect & humility within a cross functional team to establish manufacturing lines for medical devices prioritising safety, quality service, cost.
  • Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
  • Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
  • Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, 6M, timeline, Is/Is not, etc. Use statistical techniques to quantify confidence, declare assumptions, be data driven in decision making.
  • Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
  • Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.
  • Overseeing Gage Design
  • Strong GD&T skills
  • Strong SPC acknowledge


Nice To Have

  • 10+ years of experience in implants process manufacturing

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