Sr. Production Quality Engineer

Job Summary: 

 

Responsible for the coordination, control, and continuous improvement of processes and methods necessary to control the quality of purchased or fabricated parts, sub-assemblies, and finished products. 

 

 

Essential Duties and Responsibilities:

 

?  Develops and maintains processes which control the quality of parts and product throughout the procurement and production cycle. 

?  Measures, monitors and trends key metrics for the control of the production quality system.  Creates reports as required for Quality Management reviews, or for problem solving and continuous improvement activities.

?  Works with the Material Review Board, suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality continuously improves.

?  Creates and implements new processes and procedures for improving Quality through all aspects of our business.

?  Ensures that our Quality System is in compliance with all Regulatory and Quality System requirements.

 

Other duties and responsibilities:

 Shall actively lead or assist activities in the following areas;  MRB (Material Review Board), Incoming Inspection, 1st Article Inspections, CAR?s (Corrective Action Requests), CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, Quality Audits and other associated tasks.

 

Supervisory Responsibilities:

  Will lead teams as required to maintain and improve all aspects of the Quality System.  Will lead focused Quality projects or events as required, to resolve problems or make improvements to specific processes, designs, or product packaging and labeling.



 

Qualifications:

 Demonstrates strong analytical, problem solving skills.Strong written and verbal communication skills.Detail oriented,  good organizational traits.Self motivated, with strong leadership abilities.

 

 

Education and Experience:

 Bachelors of Science Degree in a Quality Management, or in an Engineering field with a strong Quality background.Experience in the Medical Device Industry and an understanding of the FDA CGMP?s preferred.Strong working knowledge of SAP preferred. (Quality Management Module)5 plus years working in a Quality Control / Assurance area.