Quality Inspector III

Gilder Search Group; Bethlehem (Northampton County); On-site; USD 30,000 - 41,000; Full time

Job summary

Gilder Search Group seeks a Quality Inspector III for an immediate temporary position in the United States. The successful candidate will inspect finished, semi-finished, and raw materials for medical devices, ensure GMP and regulatory compliance, and train staff on drawing requirements.

Strong measurement skills and GD&T knowledge are required, with experience using calipers and micrometers. The role involves occasional lifting and independent work across production stages.

Qualifications

• Solid understanding and experience using calipers, micrometers, hard gauging and other inspection tools.
• Familiar with engineering drawings.
• Strong math skills including fractions, ratios, and proportions.
• Ability to lift and move 25 pounds occasionally.
• Vision requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and focus adjustment.
• Ability to work independently with minimal supervision.
• Excellent organizational skills.
• Ability to analyze and interpret information.
• Basic GD&T knowledge.

Responsibilities

• Inspect outsourced and internal finished and semi-finished medical devices, components and raw materials to ensure conformity with product quality plans and specifications.
• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Perform visual, functional and dimensional inspections across all stages of production.
• Train others on drawing requirements.
• Communicate quality concerns with urgency.
• Apply GMP and 21 CFR 820, ISO13485, EU MDR, MDD and CMDR standards and regulations.
• Corrects or escalates quality or compliance concerns.
• Responsible for preventative maintenance activities.
• Other duties as assigned.

Skills

Calipers

Micrometers

GD&T Knowledge

Drawing Interpretation

Lifting Ability

Education

Two-year college degree or QA experience

Tools

Hard Gauging Tools

Visual Inspection Tools

Measuring Instruments

Job description

Quality Inspector III - Immediate Temporary Position!

GENERAL POSITION DESCRIPTION

The position performs inspections of outsourced and internal finished and semi- finished medical devices, components and raw materials to ensure that the product comply with product quality plans, specifications and requirements.

RESPONSIBILITIES: Primary Duties

• Ensure compliance to federal and state laws, as well as company standards and specifications.
• Perform visual, functional and dimensional inspections across all stages of production.
• Train others on drawing requirements.
• Communicate quality or concerns with urgency.
• Applies Good Manufacturing Principles (GMP) in all areas of responsibility including 21CFR820, ISO13485, EU MDR, MDD and CMDR Standards and regulations.
• Corrects or escalates quality or compliance concerns.
• Responsible for preventative maintenance activities
• Other Duties as assigned

Skills and Qualifications:

• Solid understanding and experience using calipers, micrometers, hard gauging and other applicable inspection tools.
• Must be familiar with engineering drawings.
• Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions.
• Ability to lift and/ or move 25 pounds occasionally.
• Specific vison abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Demonstrated ability to work independently with minimal supervision.
• Excellent organizational skills.
• Demonstrated ability to analyze and interpret information.
• Basic GD&T Knowledge.

Education/Experience:

• Two-year college degree or equivalent medical devise/ QA experience or equivalent combination of education and experience.
• Minimum of 1-2 years of inspection and/or production experience.
• Previous medical device manufacturing experience and a working knowledge of FDA QSR and ISO 13485 preferred.