Quality Engineer
Quality Engineer
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1 Vacancy
Job Description
- Responsible for representing the sites quality initiatives and compliance objectives in the development of methods procedures validations and quality planning for the facility.
Requirements:
- Bachelors 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. With a - Masters 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 GMPs. - 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.
Employment Type
Full Time
