Medical Device Inspector

Job Overview We are seeking a highly detail-oriented and motivated Medical Device Inspector to join our dynamic manufacturing team. In this role, you will be responsible for ensuring that all medical devices meet strict quality standards and regulatory requirements before they reach healthcare providers and patients. Your keen eye for detail, mechanical aptitude, and understanding of industry standards will help maintain our reputation for excellence. This position offers an exciting opportunity to contribute to the safety and effectiveness of life-saving medical products in a fast-paced, cleanroom environment. Responsibilities Conduct thorough inspections of medical devices during various stages of manufacturing, including assembly, packaging, and final quality checks. Utilize precision measurement tools such as calipers and micrometers to verify dimensions and tolerances according to specifications. Ensure compliance with

ISO 13485

standards, FDA regulations, and CGMP (Current Good Manufacturing Practice) guidelines throughout the inspection process. Identify defects or deviations in product quality related to plastics injection molding, soldering, hand tools, or other manufacturing processes. Document inspection results accurately and maintain detailed records for traceability and audit purposes. Collaborate with production teams to address quality issues promptly and implement corrective actions when necessary. Participate in cleanroom protocols, ensuring all inspection activities adhere to strict cleanliness standards. Requirements Proven experience with calipers, micrometers, hand tools, and other precision measurement instruments. Strong knowledge of

ISO 13485

standards, FDA regulations related to medical devices, and CGMP practices. Mechanical knowledge with hands-on experience in manufacturing environments involving plastics injection molding, assembly, packaging, or soldering. Familiarity with cleanroom procedures and protocols essential for maintaining sterile conditions during inspection processes. Ability to interpret technical drawings, schematics, and specifications accurately. Excellent attention to detail with a proactive approach to identifying quality issues early. Effective communication skills to work collaboratively across teams and document findings clearly. Join us in making a difference by ensuring the highest quality standards for medical devices that improve lives worldwide!

Pay:

$18.00 - $20.33 per hour

Benefits:

401(k)

Work Location:

In person