Quality Engineer, Tennessee

Responsibilities:

Responsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.

Requirements:

Bachelor's Degree required, preferably in Science, Chemistry, or Biology.

Minimum of 2-5 years of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical

device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred.

Master's Degree no prior work experience may be necessary.

Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk

Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong

knowledge of Health Canada GMP's.

Professional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities.

FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science

certifications (i.e. ASQ, CQE, CMQ/OE) desired.

Good verbal and written communication skills to make oral pre.

Validation, Change Control, Technical Writing, Process Mapping.

Experience with Medical Device or Pharma is a big plus.