Quality Inspector

Intertech Medical LLC; Denver (CO); On-site; USD 3,258,000 - 3,582,000; Full time

Job summary

Intertech Medical LLC is seeking a Quality Inspector for an on-site full-time hourly position in Denver, CO. You will inspect incoming materials and in-process parts, ensure GDP compliance, record data, and support ISO 13485 standards.

Responsibilities include 5S activities, NCR handling, traceability, and collaborating with engineering on tools and fixtures. A color-vision requirement and attention to quality are essential.

Qualifications

• GDP knowledge and ISO 13485 compliance.
• Able to discern color differences.
• Detect defects in molded components (DefectAwareness).
• Maintain accurate inspection documentation.
• Basic math and use of inspection tools.
• Familiarity with 5S and GMP principles.

Responsibilities

• Complete daily tasks per Intertech Policies and Procedures.
• Follow safety rules and regulations.
• Inspect incoming raw materials and in-process parts to drawings/specs.
• Record inspection data/results accurately.
• Support ISO 13485 standards.
• Maintain work order history files and final release of history files.
• Identify and resolve issues with history files including GDP issues.
• Perform 5S daily.
• Participate in complaint investigations.
• Create, monitor and complete NCRs.
• Understand, apply and audit material and product traceability.
• Apply basic inspection concepts and processes.
• Apply risk assessment and CAPA/root cause analysis.
• Perform other duties as assigned.
• Interpret data including metrics and technical information (e.g., blueprints).
• Understand GD&T.
• Assist engineering with tools, inspection programs, and fixtures.
• Inspect and record First Article Inspections (FAI) and daily inspections.
• Work independently.
• Compile work orders.
• Create Certificates of Conformity (CoCs).
• Assist in troubleshooting inspection equipment.
• Develop Quick Inspect content.

Skills

GDP

Color vision

Defect detection

PPE use

5S

Data interpretation

GD&T understanding

Quality standards

Job description

Quality Inspector

Company: Intertech Medical LLC

Primary Location: 4525 Kingston St, Denver, CO 80239 USA

Workplace Type: On-site

Employment Type:Hourly | Full-Time

Function: Manufacturing Production / Distribution

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main Duties & Responsibilities

Shift -Sunday, Monday, Tuesday, and every other Wednesday5:50am - 6:00pm

This position requires high performance in the following areas:

• Good Documentation Practices (GDP)
• Maintain high product quality, minimize product complaints
• Wear and maintain proper Personal Protective Equipment (PPE)
• Must be able to discern color differences (No color blindness)
• Must be able to detect defects in molded components by passing a DefectAwareness Test

KEY RESPONSIBILITIES:

• Complete daily tasks in accordance with Intertech Medical’s Policies andProcedures
• Complete daily tasks in accordance with safety rules and regulations
• Perform inspection of incoming raw materials and in process manufacturedparts to current drawings, specifications, and work instructions
• Record inspection data/results accurately
• Support and follow ISO 13485 standards
• Maintain work order history files and conduct final release of all historyfiles
• Identify and resolve issues with History files including GDP issues
• Perform general 5S activities daily
• Participate in and complete complaint investigations.
• Create, monitor and complete non-conforming reports (NCRs)
• Understand, apply and audit material and product traceability
• Apply basic inspection concepts, techniques and processes
• Apply risk assessment and mitigation using corrective and preventive actionprocess including root cause analysis
• Perform other duties and requests as assigned
• Ability to interpret data including business metrics and technicalinformation (example: Blueprints)
• Understanding of Geometric Dimensioning and Tolerancing (GD&T)
• Assist engineering with creating and/or modifying tools, inspection programs,and fixtures.
• Inspect and record of First Article Inspections (FAI) and daily inspections
• Ability to work independently
• Compile work orders
• Create Certificates of Conformity (CofCs)
• Assist in troubleshooting inspection equipment
• Develop Quick Inspect content

On-Site: This role is required to be on-site 5days at the Denver, COlocation.

Qualifications

• Previous injection molding, manufacturing, QA experience preferred
• Previous experience in an ISO 13485 regulated environment preferred.
• Knowledge of and use of relevant computer software applications and skills to use them effectively
• Basic math skills
• Knowledge and use of various inspection tool, methods, and techniques

Compensation

In compliance with all states and cities requiring transparency of pay, the expected pay range for this position is $23.65 - $26.00

Compensation can vary depending on several factors, including a candidate's qualifications, skills, experience, competencies, and geographic location. Some roles may qualify for extra incentives like equity, commissions, or other variable performance-related bonuses. Further details will be provided by our recruiting team during the interview process.

Benefits

Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance, Short-Term Disability, Long-Term Disability Insurance (for eligible employees), Employee Assistance Plan (EAP), Paid Time Off (may include vacation and sick time), Retirement Program, and Other Voluntary Benefits.