Quality Inspector

Nexxt Spine; Noblesville (IN); On-site; USD 25,000 - 39,000; Full time

Job summary

Nexxt Spine LLC, a leader in the medical device industry, seeks a Quality Inspector to join its Noblesville, IN team. You will inspect implants, instruments, and materials, support the Quality Management System, and ensure compliance with FDA and ISO standards.

The role emphasizes teamwork, attention to detail, and clear cross-functional communication. Responsibilities include performing IQOQPQ for equipment, identifying defects, and collaborating with Quality Engineers to drive process

Qualifications

• Ability to read and interpret blueprints or technical drawings.
• Experience with basic measurement tools and inspection practices.
• Strong communication and cross-functional collaboration skills.
• Ability to work both in a team and autonomously.
• Good judgment when evaluating inspection results and deciding on escalation.

Responsibilities

• Receive and inspect implants, instruments, and raw materials.
• Assist in establishing and maintaining the Quality Management System.
• Perform product inspections per FDA guidelines for cGMP and ISO 13485.
• Ensure adherence to quality manuals and FDA guidelines.
• Conduct IQOQPQ checks for equipment and processes.
• Identify defects, anomalies, and escalation needs during inspections.
• Support various other QA tasks as needed.

Skills

Read blueprints

Measure with calipers/micrometers

Quality inspection

Communication across departments

Team collaboration / autonomous work

Critical thinking and judgement

Tools

Calipers

Micrometers

Gauges

Job description

Nexxt Spine LLC, is a leader in the medical device industry, dedicated to designing, manufacturing, and distributing an expanding portfolio of innovative spinal implants and instruments. We are committed to a culture of innovation, excellence, and employee engagement while delivering solutions that improve patient outcomes and strengthen surgeon and distributor partnerships.

Position Summary:

Reporting to the Quality Director, the Quality Inspector will utilize quality inspection tools and practices for the effective and efficient development, transfer and maintenance of products and processes throughout the product lifecycle. The position will also collaborate with cross-functional teams to contribute to the overall success of the organization.

Essential Job Functions:

• Receive and inspect implants, instruments and raw materials.
• Assist Quality Engineer in establishing, implementing, and maintaining the Quality Management System.
• Complete product inspections in accordance with FDA guidelines for cGMP & ISO 13485
• Ensure adherence with the quality manual and FDA Guidelines.
• Perform IQOQPQ's for equipment and processes.
• Apply critical thinking and discernment when evaluating inspection results, identifying potential defects, inconsistencies, or areas of concern, and determining when issues require additional investigation or escalation.
• Various other tasks relevant to a growing business.

Qualifications:

• Basic ability to read and understand blueprints or technical drawings.
• Basic experience using measuring tools such as calipers, micrometers, and gauges.
• The ability to communicate effectively across departments and management tiers is essential.
• Preferred candidate will possess both team collaboration experience and the capability to work autonomously.
• Demonstrated ability to evaluate information objectively, ask questions, identify inconsistencies, and exercise sound judgment; particularly when requirements or inspection results require further consideration.

Physical Requirements:

• Sitting and standing for extended periods of time.
• Ability to lift up to 25 pounds.
• Hand dexterity for working with spinal implants and instrumentation.

Shift Schedule:

1st Shift: Monday-Friday, 7:00 AM - 3:00 PM