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QA AUDITOR / Sunnyvale CA

Company: Della Infotech
Location: Santa Clara
Posted on: November 23, 2020

Job Description:

Job Title QA AUDITOR Location Sunnyvale CA Duration 12 Months Job Description JOB TITLE SUPPLIER QUALITY AUDITOR Roles and Responsibilities This position has responsibility and authority to Initiate and lead Pre-Audit data gathering and cross-functional meetings. Coordinate with the suppliers for audit dates, participants, and pre-review documentation. Initiate and perform supplier evaluations as Lead Auditor. Resolve and archive all associated documentation and evidence associated with the evaluation. Initiate and lead Supplier Corrective Action Requests (SCARs) for non-conformances resulting from the evaluation. Includes all online system reporting and presentations to the SCAR Review Board. Track evaluation metrics and report to Supplier Quality. Participate in cross-functional projectprocess improvement meetings related to supplier evaluations or SCARs. SkillJob Requirements BS degree in Engineering or equivalent, MS degree preferred. Minimum 5 years related experience in Supplier Quality Engineering or related field as a Lead Auditor. o Completion of a 3rd party certification for Lead Auditor is preferred (e.g., Oriel Stat-A-Matrix, BSI, ASQ, etc.). In-depth knowledge of medical device auditing and specifically, 21 CFR part 820 and ISO 13485. Full spoken and written fluency in English is required. Multi-linguistic skills preferred. Ability to be a true team player and a partner to the cross functions teams. Partnership extends to client. Respect and consideration for client is required. Very high level of attention to detail both during audit conversations, and in presentation of written summaries. Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Written and verbal skills are most critical for the evaluation evidence presented. Proven and demonstrated ability to evaluate complex supplier capabilities especially related to QMS and technical depth. o Examples of technical depth include sterilization, MIM, machining and casting, plastics, electronics and electrical systems, motors and brakes. Experience with completing PPAP or PPQP processes preferred. Expert computer experience with Windows, MS Office, Agile, and SAP. Experience in a high-volume medical device company is preferred.

Keywords: Della Infotech, Santa Clara , QA AUDITOR / Sunnyvale CA, Other , Santa Clara, California

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