Quality Engineer

OrthoPediatrics; Warsaw (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

OrthoPediatrics is seeking a Quality Engineer to develop and implement improvements to product quality and quality systems, supporting NPD teams and legacy maintenance. You will collaborate with cross-functional teams to select manufacturing partners and conduct supplier audits.

Responsibilities include establishing quality plans, product documentation, and data-driven analysis to prevent defects, while ensuring compliance with 21 CFR 820 and ISO standards in a medical device environment.

Qualifications

• Bachelor's degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field.
• ASQ certification preferred.
• Must have computer skills; MS-Excel.
• Knowledgeable in gauging methods and their applications.

Responsibilities

• Develop, implement, and monitor adherence to product quality plans.
• Develop product documents to establish form, fit and function information for quality decisions.
• Provide quality costing information and analysis to monitor quality and identify unfavorable trends.
• Identify approved gauging and measurement techniques.
• Specify measurement equipment and improve gauging methods.
• Ensure compliance with internal and customer imposed quality standards.
• Reduce cost by eliminating or reducing non-conforming materials and/or products.
• Diagnose and assist in the resolution of quality problems and implement programs to improve product quality.
• Conduct supplier and internal quality system audits according to established schedules and quality standards.

Skills

Teamwork

Product knowledge

Statistics / SPC

Non-destructive testing

Communication skills

Data interpretation

Designed experiments

Problem solving

Regulatory knowledge

Education

Bachelor's degree in engineering related field

Tools

MS Excel

Microsoft Word

PowerPoint

MS Outlook

Job description

GENERAL SUMMARY:

The Quality Engineer develops and implements improvements to product quality and quality systems and supports New Product Development teams, as well as maintenance on legacy systems. Works with cross-functional teams to determine high‑quality manufacturing partners, and conduct supplier audits.

ESSENTIAL FUNCTIONS:

• Develop, implement, and monitor adherence to product quality plans.
• Develop product documents to establish form, fit and function information which can be used as a basis for making quality decisions.
• Provide quality costing information and analysis to monitor quality and identify unfavorable trends.
• Identify approved gauging and measurement techniques.
• Specify measurement equipment and improve gauging methods.
• Ensure compliance with internal and customer imposed quality standards.
• Reduce cost by eliminating or reducing non-conforming materials and/or products.
• Diagnose and assist in the resolution of quality problems and implement programs to improve product quality.
• Conduct supplier and internal quality system audits according to established schedules and quality standards.

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 work in a strong team environment.
• Be an expert on new products and company information.
• Proficient in the use of statistical applications; must be familiar with the use of SPC.
• Knowledge on non‑destructive testing and measuring techniques.
• Must have excellent verbal and written communications skills.
• Must be analytical and can interpret data.
• Must be familiar with the use of designed experiments.
• Ability to solve problems.
• Strong working knowledge of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971)

EDUCATION AND/OR EXPERIENCE:

Requires a Bachelor degree in Industrial Engineering, Industrial Technology, Mechanical Engineering, Engineering Technology or related field. ASQ certification preferred. Must have computer skills; (MS-Excel). Knowledgeable in gauging methods and their applications.

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.