ENERAL SUMMARY: The Quality Inspection Specialist will perform product quality assessments on finished medical devices or medical device components received from Orthopediatrics’ suppliers to determine conformance to specific requirements and specifications.

Essential Functions:

• Perform regular quality inspections on received finished medical devices or medical device components using appropriate gaging, inspection methods, industry best practices, and Orthopediatrics’ processes/procedures.
• Operate within the regulations and guidelines in accordance with ISO 13485, current Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and other applicable Orthopediatrics’ procedures.
• Utilize appropriate inspection related software to input inspection results, establish conformance of inspected product, and evaluate supplier provided inspection data.
• Ensure inspection work areas are kept clean, safe and in an orderly manner.
• May help assist with the training of new team members as needed.
• Assist in other operational areas as needed.

SUPERVISORY RESPONSIBILITIES:

There are no supervisor responsibilities with this position.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Ability to read and interpret product drawings/prints and specifications.
• Ability to work in a strong team environment.
• Must have excellent verbal and written communications skills.
• Ability to solve problems.
• Ability to perform detail tasks accurately
• Ability to maintain accurate documentation and records

EDUCATION AND/OR EXPERIENCE: Minimum of 2 years of product quality inspection experience in the medical device field. Knowledgeable in commonly used product quality inspection methods, gauging, and equipment. ASQ certification preferred. Must have computer skills (Microsoft Office).

LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors, and other employees of the organization. Requires excellent grammar and spelling

MATHEMATICAL SKILLS:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

REASONING ABILITY: Ability to carry out instructions furnished in written, oral, or diagram form. Ability to use critical thinking to deal with problems involving multiple variables in a variety of situations.

CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver’s license.

Other Skills and Abilities Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

PHYSICAL DEMANDS:

(The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

The noise level in the work environment is that found in a “normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel.

The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.