gmp Quality Validation Engineer
4 weeks ago
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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