Process Quality Engineer - #1782770

Pls Note: Client's expectation is from medical device/pharma field, so please get the profiles from the same field.

To Be filled by Hiring Manager - To share with Candidate*

Job Role (Define At least 6 points which candidate is supposed to do)

Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.

Supports new Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.introduction as part of design transfer.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk

Collect data and execute/conduct various analytical/statistical analysis and interpretations as part of process improvements and day-to-day support.

Develop, interpret and implement standard and non-standard sampling plans

Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

Accountability and ownership for sampling plans of all types including the acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standards for manufacturing data.

Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs,

Hands On Experience Is Preferred

Mandatory Skills*

Technical / Soft Skills

Expertise Level (Expert / Good / Knowledge)

Remarks

Manufacturing processes

Knowledge

Lean and Six Sigma, Measurement System Analysis, SPC, DOEs, Reliability

Good

statistical software packages

Good

MS office

Good

Regulatory compliance (FDA and European regulatory), GMP

Good

Desired Skills

Technical / Soft Skills

Expertise Level (Expert / Good / Knowledge)

Remarks

• Strong interpersonal and excellent communication skills with good team spirit.
  
  

Expertise

• Problem solving abilities, data analysis and interpretation
  
  

Good

• `Experience in Medical Devices Manufacturing - Preferred
  
  

Good