Supplier Quality Engineer - (US-NJ-Mahwah)
Supplier Quality Engineer - (US-NJ-Mahwah)
Compensation: $75K - $85K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: S8006BRJA
Experience Required : 5 - 10 years
Travel Required : to 50%
PAID RELOCATION AVAILABLE
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:
Liaise 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 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
Candidate Must Have :
* 5+ years experience in a medical device or other regulated industry.
* Bachelor’s degree in Mechanical or Industrial Engineering.
Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.
NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.
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