10 SUPPLLIER QUALITY ENGINEER - AUDITOR

Job Title10 Supplier Quality Engineers-Auditors Needed asap for Medical Device Industry



PLEASE FORWARD RESUME TO: JONF_SCOTTSTAFF@YAHOO.COM
Business FunctionRegulatory/Quality/Clinical AffairsShift1stEducation and/or Special TrainingEDUCATION:
Bachelor’s degree in Engineering. (Mechanical/Industrial preferred) Master’s degree, six sigma black belt, ASQ CQE (certified quality engineer) preferred. Internal or lead auditor certification (ASQ CQA) a plus..Job DescriptionJOB DESCRIPTION:

1. Responsible for providing technical support to internal customers and suppliers for activities related to supplier quality system assessment, performance evaluation and supplier development.
2. Will work with internal customers and suppliers in support of supplier selection, supplier development and certification, and the establishment of process equivalence.



ESSENTIAL DUTIES AND RESPONSIBILITIES:
Liase with internal customers to support supplier development and certification. Lead and performs supplier quality system audits on new and existing suppliers to 21CFR 820, ISO 13485:2003 and other applicable Standards to assess a suppliers' capabilities and ability to meet Corporate and regulatory requirements. Work with new and existing suppliers develop internal processes and controls using; 6 sigma tools, root cause analysis, process capability assessment (Cpk), process validation, statistical techniques, gage R&R, pFMEA, control plans, and mistake-proofing (poke-yoke). Work with new and existing suppliers in support of supplier certification activities, including product source and skip-lot inspection. Assist in the development, review, approval, implementation and/or training of process and equipment validations. Issue corrective action requests to suppliers in response to audit findings and/or internal Stryker issues. Ensure effective closure, by working with suppliers to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits. Maintain supplier database, files and approved supplier list (ASL). Develop and conduct effective training programs on related QA topics.Qualifications/Work ExperienceQUALIFICATIONS:
2+ years experience auditing and/or Quality Engineer Experience in a medical device or other regulated industry preferred. CQE, CQA, and/or Black belt certification preferred. Project Management experience. High level of PC Proficiency. Strong interpersonal, organizational and written/verbal communication skills. Ability to understand technical drawings and GD&T. Self starter with demonstrated analytical and problem solving skills. Ability to manage multiple tasks in a fast paced environment. Self-motivated with the ability to effectively work with others in various coordinate disciplines, on multi-national teams, and to prioritize tasks in a deadline-driven environment.Percent Travel Required

15-30%

 

PLEASE FORWARD RESUME TO:

JONF_SCOTTSTAFF@YAHOO.COM