Principal Level Quality Engineer- MUST HAVE Validation experience, CAPA, Minitab

• Responsibilities may include the following and other duties may be assigned.
• Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.

Must Have

• Ability to use statistical techniques to analyze data
• Design of experiment/Process Characterization
• Experience working in a fast paced Manufacturing environment
• Validation Experience (IQ, OQ, TMV, PQ) • CAPA (Corrective Action / Preventive Action) Experience
• Familiarity with Minitab Statistical Software

Nice To Have

• A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T.
• Experience in mechanical assembly and components.
• Ability to work with vendors on dimensions and order components.
• Ability to qualify equipment in medical device mfg. assembly line.
• Experience in working in a med device company in a cleanroom environment.

Required Knowledge and Experience:

Requires a University Degree and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.