Blueprints, Calibration, Cleanroom, Cross-Functional, Detail Oriented, Documentation, FDA Requirements, GMP (Good Manufacturing Practices), Healthcare Quality, Healthcare Software, ISO (International Organization for Standardization), Identify Issues, Internal Audit, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing, Manufacturing Audit, Manufacturing Equipment, Manufacturing Requirements, Medical Equipment, Patient Care, Problem Solving Skills, Product Support, Production Support, Quality Control, Receiving Inspection, Regulations, Testing
Quality Control Inspector – 2nd Shift
In this role, you will play an important part in ensuring our Class III molded medical devices meet the highest standards for quality, safety, and regulatory compliance. Our products include cream applicators, tablet applicators, suppository applicators, and glass and plastic dropper assemblies used in critical healthcare applications.
This is a great opportunity for someone who enjoys hands-on inspection work, takes pride in attention to detail, and wants to contribute to products that directly support patient care.
What You’ll Do
- Perform visual and dimensional inspections at receiving, in-process, and final inspection stages
- Conduct AQL sampling to verify product quality and acceptance criteria
- Inspect labels and packaging components for accuracy and compliance
- Complete inspection documentation and records in accordance with GMP guidelines
- Follow required gowning and cleanroom protocols
- Initiate Non-Conforming Material Reports (NCMRs) when quality issues are identified
- Perform internal audits of manufacturing areas to ensure compliance with procedures
- Conduct basic calibration of inspection gauges and manufacturing equipment
- Perform packaging inspections, including seal checks and visual inspections for particulates or cosmetic defects
- Use inspection tools such as calipers, micrometers, tensile testers, scales, and go/no-go gauges
- Verify machine settings such as temperature, cycle times, and process parameters
- Work closely with operators, engineers, maintenance, and management to support quality and production goals
- Lift up to 25 lbs as needed
What We’re Looking For
- 2–4 years of quality inspection experience, ideally in a regulated manufacturing environment
- Familiarity with GMP guidelines and quality documentation practices
- Ability to read and interpret blueprints, specifications, and manufacturing documents
- Experience using precision inspection tools and measurement equipment
- Strong attention to detail and problem-solving skills
- Ability to work independently while collaborating with cross-functional teams
- High school diploma or equivalent required
- Basic computer skills for documentation and reporting
Preferred Experience
- Experience in medical device manufacturing, especially Class III devices
- Knowledge of ISO 13485 quality systems and FDA regulations
If you are a detail-oriented quality professional who takes pride in ensuring products meet strict regulatory and performance standards, we encourage you to apply and join a team committed to producing high-quality medical devices.