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Quality Engineer

4 months ago

Jacksonville, United States LanceSoft, Inc. Full time

NO C2C/ H1B


Job Description:

Bachelors’ degree in Engineering, Science or Technical field. Minimum of 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality. Experience in Validation/ Qualification Activities: Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR. Experience in Risk Documentation: Write, review, approve of Riks Management files, RPM calculations, Risk Mitigations. Sampling size determination: For Attribute or variable data. Strong statistical background. Able to work with minimum of supervision in a hybrid working organization set up. Good writing and documentation skills. Good organizational and verbal communication skills. Ability to work in fast-track schedule and meet deliveries on time. Ability to communicate effectively. Ability to interact with a very diverse team keeping high ethics standards. Demonstrate commitment with the Core Values. Strong Risk Management Experience


ASQ Quality Engineer Certification. Bilingual English/ Spanish preferred but not required. Previous Medtronic and/or Medical Device experience is helpful. DMAIC Lean / Six Sigma Certification. Manufacturing experience within a controlled and regulated industry.