Quality Assurance Inspector

Shelby American, Inc.; Huntersville (NC); On-site; USD 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Inspector to ensure the highest standards in the manufacture of medical supplies and devices. In this vital role, you will perform quality control inspections, oversee production processes, and contribute to maintaining compliance with quality assurance protocols. Your expertise will help improve processes and uphold safety standards, making a significant impact on the quality of medical products. If you have a keen eye for detail and a passion for quality assurance, this opportunity is perfect for you to grow in a supportive environment.

Qualifications

• 3+ years in Quality Control or Assurance in a medical device field.
• Proficient in using PC programs, especially Excel, Word, and Visio.

Responsibilities

• Perform inspections during production and ensure compliance with quality standards.
• Assist in developing procedures for testing and inspection of medical devices.

Skills

Quality Control

Statistical Methods

Document Interpretation

Effective Communication

Problem Solving

Education

High School Diploma

Tools

Excel

Word

Visio

Job description

Job Summary

The Quality Inspector is responsible for performing quality control inspections, checks, and tests during the manufacture of sterile and non-sterile medical supplies and devices. Inspect materials, parts and products at different stages of production. Records observations and may make recommendations for improving processes.

Essential Job Functions

• Perform line inspection prior to production runs; review/approve line clearance documentation.
• Perform line inspection and release of product labeling prior to production, perform label reconciliation and final record review at completion of production runs.
• Perform in-process inspection of product during production runs; final inspection of product at completion of production runs.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Assist in the development of procedures for the test and inspection of articles.
• Perform incoming inspection and release of medical devices, device materials, components and subassemblies.
• Assist with root cause analysis and investigation write-ups for quality related issues.
• Responsible for writing and/or assisting in the writing of test and inspection SOPs.
• Other duties as assigned.

Qualifications

• High School diploma.
• 3+ years in a Quality Control or Quality Assurance position with a medical device manufacturer or related field.
• Proficiency in the use of PC and programs, particularly Excel, Word, and Visio.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Knowledge of testing equipment, statistical methods, control plans.
• Strong work ethic and understanding of basic Quality systems.
• Able to work well independently.
• A strong and dedicated understanding of customer and company needs and basic requisites.
• Ability to speak effectively before groups of customers or employees of organization.
• Ability to maintain records, and prepare reports and correspondence related to the work.
• Ability to conduct investigative interviews.
• Knowledge of federal and departmental quality control policies.

Competencies

• Demonstrates ownership and accountability.
• Demonstrates the ability to plan, execute, control and deliver.
• Communicates effectively both written and verbal.
• Lead and influence others effectively.

Physical Requirements

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping, reaching, lifting, carrying, bending/stooping, kneeling/crawling, climbing, balancing, pushing/pulling, vision requirements - close vision.

Mental Requirements

This position requires the ability to maintain an appropriate work pace, comprehend and follow instructions, exercise logic and reasoning, organize and prioritize, read, compose written communication, communicate verbally, problem solve, count and compute, and multi-task/re-direct. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Work Environment

The noise level in the work environment is usually quiet to moderate.

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.