CA: QC Engineer (234122)

Life Sciences & Technology | Validation


3-6 months possible extension

Job Description:

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.

Special Skills:

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)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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