Quality Control Inspector II

HireTalent

Newark, DE

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JOB DETAILS

SKILLS

Agile PLM / Oracle PLM (Product Lifecycle Management), Blueprints, Cleanroom, Continuous Improvement, Detail Oriented, Document Management, Documentation, Documentation Review, Electronics, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High School Diploma, High Voltage (HV), Housekeeping/Cleaning, Lift/Move 40 Pounds, Manufacturing, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft SharePoint, Microsoft Word, Oracle ERP, Physical Demands, Presentation/Verbal Skills, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Record Keeping, Sales, Schematics, Standard Operating Procedures (SOP), Team Player, Testing, Writing Skills

LOCATION

Newark, DE

POSTED

23 days ago

INTAKE:
Pay Rate Range: *** - ***/hour (not including 2nd shift differential)
6 month assignment
Must be onsite - 100% onsite

M-F; 2nd SHIFT: 2:30AM to 11:00PM
NEED TO BE AVAILABLE TO TRAIN ON 1st SHIFT
- first 3-4 weeks will be on 1st shift training before moving to 2nd shift.
1st shift hours: 6am - 2:30pm
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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
Three total openings
Contingent staff augmentation assignment

Shift and Schedule

Second shift role
Standard hours are 2:30 PM to 11:00 PM
Initial training required on first shift for approximately the first 3 to 4 weeks
First shift training hours are approximately 6:00 AM to 2:30 PM

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

Interview Process

Initial phone interview
On site interview with hiring team

Resume Screening Signals
Positive Signals

Experience in regulated manufacturing or quality environments
Experience with documentation review and inspection activities
Demonstrated attention to detail and compliance mindset

Red Flags

No exposure to regulated environments
No manufacturing or quality related experience
Inability to meet second shift requirements

Experience Level Guidance

Target profile is early career to mid level quality or manufacturing professionals
Candidates with less experience may be considered if background is relevant
Candidates with more experience may be considered if interested in the role scope

Temp to Perm and Tenure Language

Assignment length is six months from individual start date
Potential for extension or conversion is not guaranteed
Pay rate range is *** to 31 per hour base
Second shift differential applies per site policy
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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

About the Company

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