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Quality Eng Quality Engineer II/III
Ref No.: 18-04819
Location: Hercules, California
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
 
Job Details:
•        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.
 
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.