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Greetings from Intelliswift Software Inc.
We are looking for a Quality Eng Quality Engineer . If interested, please send us your updated resume and a suitable time when we could discuss this opportunity:
Job Title : Quality Engineer III
Duration : 6 Months & Possibility of Extension
Location : Hercules, CA
• Provide technical and quality systems guidance into content of validation and qualification plans, protocols and reports.
• Review and approve validation activities in support of manufacturing, logistics and design control processes.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Maintain, revise and assess multiple site Facilities Master Validation Plans.
• Partner with Global Supply Chain sites to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed..
• Participate in various Change Control activities, including review and approval of change management plans, verification activities, etc.
• Able to apply statistical methods in support of the validation and change control processes, including Statistical Process Control, Measurement Systems Analysis, and Design of Experiments.
• Support the deviation and nonconforming product processes.
• Evaluate and improve QMS procedures and training material as required.
• Work with process development/tech transfer group on IQ, OQ, PQ, Software Validation acceptance criteria.
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• Support other quality and compliance activities as required.
• Bachelor’s Degree, preferably in Engineering or related technical field.
• 3+ years’ experience in Quality position supporting manufacturing/operations within Biotech or medical device industry is required
• Thorough understanding of ISO-13485 and ISO-14971; knowledge of ISO-62366 a plus.
• Experience with process validations, design verification and design validation studies is preferred including Measurement System Analysis, SPC (Statistical Process Control), DOEs, Reliability, etc.
• Understanding of statistical methods, statistical process control and sampling plans.
• Detail oriented with excellent organizational and project management skills.
• Excellent verbal and written communication, problem solving, analytical skills required.
• Critical thinking skills, ability to multitask in a high-paced environment with fast deadlines, and ability to work well under pressure.
• Working knowledge of SAP, MS Word, MS Excel, MS PowerPoint, Minitab.
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Intelliswift Software is an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.