Must haves for this position:
-Prior experience as a R&D in a medically regulated industry (Class II or III highly preferred)
-Design verification and validation experience in the medical device industry
-Exposure to failure mode analysis.
-PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
-Test method validation
-Design verification (plans & protocols), reporting, and testing
-Data failure analysis on the design verification testing
Job Responsibilities:
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
• May write training material and conduct training sessions on quality control activities.
• May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.
Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.