20 Π΄Π½Π΅ΠΉ Π½Π°Π·Π°Π΄
Quality Lead Inspector (Medtech)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Quality Lead Inspector (Medical Devices): Leading daily quality inspection operations and coordinating inspector workloads for medical device production with an accent on regulatory compliance, measurement equipment verification, and non-conforming material control. Focus on training inspectors, applying sampling standards, scheduling inspections, and driving quality system improvements.
Location: Jeffersonville, IN, United States; onsite work in production and cleanroom environments
Company
operates in the medical manufacturing and quality environment.
What you will do
- Lead daily inspection activities and coordinate the workload of quality control inspectors.
- Oversee inspection and testing of work-in-process, raw materials, finished products, parts, and materials.
- Perform operational, preventive maintenance, and accuracy checks on measurement and test equipment.
- Manage non-conforming materials, including segregation and disposition according to MRB requirements.
- Schedule inspection activities, resolve complex quality issues, and drive system improvements.
- Maintain inspector timecards, approve payroll, and submit requests for quality control supplies and equipment.
Requirements
- High school diploma or equivalent GED.
- At least 8 years of experience in quality-related roles.
- Comprehensive knowledge of medical device regulations and quality systems, including ISO 13485 and FDA 21 CFR Part 820.
- Experience leading teams, mentoring inspectors, and implementing quality initiatives and preventive actions.
- Experience with SAP and MasterControl, with focus on data integrity and compliance.
- Ability to stand for long periods, perform fine motor tasks, lift up to 50 lbs., and work in cleanroom environments.
Culture & Benefits
- Full-time employment.
- Equal opportunity workplace committed to diversity and inclusion.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β