3-6 months possible extension
Our client is looking for a Sr QC Engineer Consultant to bring their legacy QC systems into the new age. The company has been around for a while but working off legacy systems. The ideal candidate will have surgical single use device experience with a minimum of 10 years total industry experience to come in and preform a gap assessment between what they are currently doing and what needs to be done to meet todays standards. All departments from receiving inspection, measuring equipment, molding equipment, sharpening department, gama sterilization, packaging, sealing, and labeling, distribution, etc. Once the gap assessment is made and all stakeholders agree this person will need to begin working dept by dept closing the gaps. This includes but is not limited to creating new documentation, new check lists for operators, new receiving inspection criteria, new charts/spreadsheets, verification check lists prior to shipping, etc. This client uses a paper based system.
To be successful at this, the candidate should have a working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, problem solving tools, and statistical techniques and application experience.
Quality Tools (Quality Planning, Costs, Assessment, Basic +/or Advance Statistical Techniques, Tech Writing, Metrology & Calibration, Inspection & Testing, Sampling Principles & AQL, TQM, Six Sigma
Problem Solving Tools – Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis, Information Technology Skills – Windows, Word, Excel, Access, Power Point, Project, Visio , statistical software usage & principles
Strong written and oral communication and interpersonal skills.
Working knowledge of FDA regulations and experience with managing external agency audits necessary.
Certified ASQ CQE and/or Lean Six Sigma Green belt preferred. Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.
CA: QC Engineer (234122)