Quality Engineer

OrthoPediatrics; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

OrthoPediatrics, a pediatric orthopedic company, seeks a Quality Engineer to develop and improve product quality systems and to support New Product Development teams as well as legacy system maintenance.

You will work with cross-functional teams to select manufacturing partners, conduct supplier audits, and ensure adherence to 21 CFR 820, ISO 13485, and ISO 14971 standards.

Qualifications

• Bachelor's degree in a related field; ASQ certification preferred.
• Experience with medical device quality systems and regulatory requirements.
• Proficient in statistical methods and DOE; able to analyze data.
• Strong communication and teamwork capabilities.

Responsibilities

• Develop, implement, and monitor adherence to product quality plans.
• Create documents defining form, fit and function for quality decisions.
• Provide quality costing information to monitor trends.
• Identify approved gauging and measurement techniques.
• Specify measurement equipment and improve gauging methods.
• Ensure compliance with internal and customer quality standards.
• Reduce cost by eliminating non-conforming materials/products.
• Diagnose quality problems and implement improvement programs.
• Conduct supplier and internal quality system audits per schedule.

Skills

Teamwork

Product knowledge

Statistical software

SPC

Non-destructive testing

Communication skills

Data analysis

Design of Experiments

Problem solving

Regulatory knowledge

Education

Bachelor's degree in Industrial Engineering (or related field)

ASQ certification preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

PowerPoint

Job description

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics' global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

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:

• 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:

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 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.