*Location: Ft. Worth, Texas Duration: 6+ Interview mode: Phone then Skype Duties: The Validation Engineer will ensure proper validation of equipment and measurement/inspection systems used for both production and Design Testing. *This position will be an integral part of R&D in support of Design Verification and Design Transfer activities.
* The ideal candidate will have a firm understanding and practical experience with Medical Device Quality System Regulation requirements (21 CFR 820), cGMP/GxP requirements and key industry validation principles/guidance documents (GHTF). *The Validation Engineer will actively participate in the design and development of overall validation strategies, write individual test plans/protocols using appropriate statistical techniques and following a risked-based approach to validation, manage validation execution including deviations, review/analyze validation results and write validation reports. * Skills: * *Dept at partnering with various Subject Matter Experts (project team members, scientists, engineers, QA, etc.) in order to create and execute validation strategies consistent with operational and compliance needs *Must be able to write and execute measurement/inspection systems equipment Validations including Computerized Software Validations (CSV) Able to use and apply Six Sigma methodologies and tools such as; GRR, Process Capability, DOE Must be able to use statistical analysis software such as; Minitab, JMP, etc. Excellent verbal and written communications Strong decision making and problem solving skills * PRINCIPAL RESPONSIBILITIES: *Ensure timely execution of equipment validation activities in support of project objectives and in compliance with local SOPs. Develop and implement verification and validation documentation (i.e. Master Validation Plans, IQ/OQ/PQ/CSV/TMV protocols and summary reports) in collaboration with Instrumentation Engineers, Users and Quality Ensure responsible departments execute activities according to applicable SOPs and Validation Master Plan(s) Partner with Quality and other area/site validation leads to establish and maintain common validation approach for the sites. Partner with Quality and other functional areas to define process validation strategies Develop statistical sampling plans; Perform statistical analysis of test data (i.e. Hypothesis Testing, Normality Testing) Perform or oversee risk assessments for Validations * QUALIFICATIONS: This position will require a minimum of a Bachelor's Degree in Engineering or a scientific discipline with a minimum of 5 years work experience in the Medical Device Industry and a minimum of 2 years validation experience with Medical Devices. *Preferred experience in computer systems validations and Measurement System Analysis (MSA). Design Control experience and Certification as a Six Sigma Green Belt or Black Belt a plus. Part 11 compliance knowledge is a plus. * KEY WORDS: Test Method Validation Measurement System Analysis (MSA/GRR) *Process Validation Computerized System validation (CSV) QSR 21 CFR 820 GHTF IQ, OQ, PQ Thanks Regards *Swami A* Technical Recruiter *Ennovace Inc* Ph: 214-541-9378 F: 972-262-9006 [email protected] www.ennovace.com 1801 S O'connor Rd Irving TX 75061 In my absence please contact Steven at [email protected] (214-541-9081) Disclaimer: We respect your Online Privacy. This e-mail message, including any attachments, is for the sole use of the intendedrecipient(s) and may contain confidential and privileged information.Any unauthorized review, use,disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line at [email protected] and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. -- You received this message because you are subscribed to the Google Groups "Associate Programs" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/associate_programs. For more options, visit https://groups.google.com/d/optout.
