Quality Control Inspector II

Job Title: Quality Control Inspector II (Onsite)

****: $$$$ $$$$/hour

Location: 600 Technology Drive Newark DE 19702

Duration: 06 months Possible Extension/Conversion

Schedule: M-F; 2nd SHIFT: 2:30AM to 11:00PM NEED TO BE AVAILABLE TO (TRAIN ON 1st SHIFT - 1st shift hours: 6am - 2:30pm)

Role Environment and Scope

• QC Inspector II role within a regulated medical device manufacturing environment.
• Work is 100 percent on site.
• Responsibilities include device history record review documentation verification physical inspection and final quality signoff.

Required Capabilities (Must Screen For)

• High school diploma or GED.
• Ability to lift and move up to 40 pounds.
• Prior manufacturing or quality experience appropriate for a Level II role.
• Strong attention to detail.
• Ability to follow SOPs and controlled documentation.
• Reliability and consistent attendance.
• Willingness and ability to work second shift.

Preferred Qualifications (NOT deal breakers)

• One to two years of quality or manufacturing experience.
• Medical device industry experience.
• GDP and GMP experience.
• Experience in other regulated industries such as aerospace or pharmaceutical.
• PPE and Dress Code (Interview critical).
• Standard manufacturing and quality PPE as required on site.

Job Summary

• Performs inspections testing and sampling procedures for product manufacturing. Includes packaging line and incoming material checks. Reviews and releases Device History Records.
• May assist with validation or troubleshooting of testing methods.
• Routine assignments with limited judgment.
• Acquires job skills and follows company procedures.
• Works under moderate supervision.
• Essential Duties and Responsibilities.
• Maintain and promote a safe work environment.
• Conduct inspections of in-process and finished goods.
• Record and maintain quality control documentation.
• Support investigations into non-conforming products.
• Support process audits for SOP and WI adherence.
• Initiate Non-Conforming Events (NCEs).
• Review device history records and sales orders.
• Participate in Kaizen and continuous improvement initiatives.
• Complete training requirements and maintain records.
• Regular punctual attendance and ability to work overtime.

Physical Demands

• Sit stand walk reach stoop kneel crouch crawl
• Lift/move up to 40 pounds
• Exposure to mechanical parts vibration moderate noise
• Safety shoes required in designated areas
• May work with high voltage electronics radiation clean rooms controlled environments or dark rooms

Qualifications

Education

• Minimum: High School Diploma or GED
• Associate Degree preferred

Experience

• 1-2 years preferred
• Quality assurance or manufacturing experience beneficial.
• Experience in FDA-regulated medical device environment beneficial.
• Familiarity with Oracle ERP or Agile PLM beneficial.

Skills

• Basic Microsoft Office (Excel Word SharePoint OneDrive).
• Ability to follow written procedures.
• Effective written and verbal communication.
• Teamwork and independent work capability.
• High attention to detail.
• Ability to read schematics and blueprints.
• Familiarity with GMP and GDP.