gmp Quality Validation Engineer - Minnetonka, United States - Medvacon Life Sciences

Description

cgmp Quality Validation Engineer

NO AGENCIES
W2 only
On-site position
6+ months

Leads validation and quality engineering activities

for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations.


SCOPE:
Owner

of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

RESPONSIBILITIES:
validation plans, protocols and reports for assembly and packaging processes
validation standard operating procedures in compliance with regulatory requirements
validation protocol and report templates
test method validation (TMV) protocols and reports for automated and manual inspection methods.
quality engineering support for semi-manual and automated equipment development equipment
URS, FAT/SAT against quality requirements.
support design transfer of internal manufacturing processes.
statistical analysis of validation and production data
manufacturing process development & qualification for product changes
continuous improvements
leads CAPA/NCR/SCAR investigations and reports.
internal & external audit
complaint investigations


REQUIREMENTS
Bachelor's degree in engineering (Mechanical or Biomedical) or related Science
5-7 years relevant experience within medical device industry or related function
ASQ certification a plus
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