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| File No. |
EFB2E3 |
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| Location |
New Cumberland |
| Designation/Title |
Quality Manager |
| Profile |
- Effectively manage processes and personnel to ensure the quality
of incoming, in-process, and finished medical devices. Work is performed in
keeping with production deadlines and customer needs.
- Review product specifications and quality requirements for
regulatory compliance and determine necessary product requirements not
specified by the customer. Requirements developed include dimensional
tolerances, functional performance, packaging, and labeling.
- Responsible for the development, maintenance, and audit of the
requirements, methods, and procedures of an effective Quality Management System
in compliance with ISO 9001, ISO 13485, and 21CFR standards for medical device
design, development, manufacturing, labeling, and distribution. Responsible for
developing and implementing a Quality Management System that received
accredited certification for compliance with requirements of both ISO 9001:2000
and ISO 13485:2003. Consistently received a Quality rating of 90 or greater
from major customer BBraun Medical, Inc.
- Maintain both electronic and hard files for document control.
Electronic files maintained in MS Excel, MS Word, Access, and Acrobat software.
- Develop and implement process validation protocols and analyses of
validation results to ensure that production processes and equipment are
controlled and are capable of consistently producing product that meets
established specifications and quality requirements. Processes validated
include vision inspection systems, injection and compression mold processes,
and Controlled Environment cleaning.
- Obtain and review qualifications of potential suppliers to ensure
that the product or services provided meet established requirements. Also
perform periodic audits of current suppliers to ensure continued compliance
with regulatory standards and identify opportunities for improvement.
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