*Job Title* *Mechanical Engineer (Sustenance Engineering)*
*Work Location* *Irvine, CA* *Relevant Experience * · A minimum B.S. in Mechanical Engineering with 6 - 8 years of related experience. · A minimum of 5 years of experience in product design, sustenance engineering is required, CAPA is required. * * *Technical/Functional Skills* · *Experience Required* Strong Mechanical engineering skills (basic knowledge) with working knowledge of product design and sustenance engineering activities. · Experience and working knowledge of initiating, completing and supporting Non conformance report (NCR), CAPA, etc. · Demonstrate leadership in organizing and driving solution based teams to ensure compliance to process requirements and the consistency/quality of CAPAs and NCs. Lead root cause analysis investigations and drive continuous improvement efforts on an ongoing basis. · Knowledge and understanding of CAPA and NC system regulations and standards (e.g. ISO9001, ISO13485, FDA 21CFR820.100) · Good team work and interpersonal skills. Provides project direction, coaching, and mentoring for CAPA teams as required. . · Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA and NC issues. · Use technical/compliance information to guide and influence CAPA/NC/Compliance strategies. · Strong project management and organizational skills excellent verbal and written communication skills. · Strong analytical and problem solving skills. Excellent attention to detail, resourceful, self-reliant, self-motivated and confident · Experience in medical device quality control/assurance is preferred. Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and risk management tools, such as, Risk Analysis, FMEA and FTA. The qualified candidate for this hands-on position should be able to use Mechanical Engineering principles, tools, and practices to determine root cause of component failure and develop and implement corrective/preventive actions that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting supporting product design, sustenance activities, product and quality improvement activities, etc. *Roles & Responsibilities* · Suggest and implement product / quality improvement initiatives · Perform Product design, sustenance engineering activities as per company requirement · Initiate, support and complete Non conformance report (NCR), CAPA, etc. * * *Education* A minimum B.S. in Mechanical Engineering with 6 – 8 years of related experience. Thanks and Regards, ____________________ *Karan Tyagi*** *IDC Technologies, Inc*., 1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA, 95035 Tel: 408-457-9381 Extn: 4069| Fax: 408-608-6088 Email: [email protected] <[email protected]>| Web: www.idctechnologies.com| Yahoo IM: Karan_tyagi2000, Gtalk IM: itrecruiter2012 "Under Bill s. 1618 Title III passed by the 105th U.S. Congress this mail can not be considered spam as long as we include a way to be removed from our mailing list. Simply send us an e-mail with REMOVE in the subject and we will gladly REMOVE you from our mailing list." -- You received this message because you are subscribed to the Google Groups "MCMS" 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/mcms. For more options, visit https://groups.google.com/groups/opt_out.
