Supplier Quality Engineer

OrthoPediatrics Corp.; Warsaw (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

OrthoPediatrics Corp. seeks a Supplier Quality Engineer to drive product quality and quality systems across suppliers and to partner with cross-functional teams to select high-quality manufacturing partners and conduct supplier audits.

Responsibilities include defining supplier quality activities, enforcing quality requirements, tracking metrics, managing CAPA and deviations, and guiding supplier approvals while interfacing with external auditors.

Qualifications

• Bachelor’s degree in Engineering or related quality field.
• ASQ certification preferred.
• 5 years of medical device quality experience preferred.
• Proficient with MS Excel and data analysis tools.
• Familiar with ISO 13485, 21 CFR 820, ISO 14971.

Responsibilities

• Define and manage supplier quality activities.
• Develop, implement, and monitor supplier quality requirements.
• Generate and monitor supplier quality metrics.
• Manage supplier CAPA, non-conformances, deviations, and changes.
• Conduct supplier and internal quality system audits.
• Manage the quality approval of new suppliers.
• Interface with external auditors.

Skills

Teamwork

Statistical analysis

SPC

Data interpretation

Analytical thinking

Education

Bachelor's degree in Engineering

ASQ certification preferred

Tools

MS Excel

MS Word

PowerPoint

MS Outlook

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.

Supplier Quality Engineer

Job Description

GENERAL SUMMARY:

The Supplier Quality Engineer develops and implements improvements to product quality and quality systems at all currently approved and newly identified suppliers. Works with cross-functional teams to determine high-quality manufacturing partners and conduct supplier audits.

ESSENTIAL FUNCTIONS:

• Define and manage all supplier quality activities.
• Develop, implement, and monitor adherence to supplier product quality requirements.
• Generate and monitor supplier quality metrics.
• Manage supplier CAPA, non-conformances, deviations, and requested changes.
• Conduct supplier and internal quality system audits according to established schedules and quality standards.
• Manage the quality approval of new suppliers.
• Understanding of contracts and legal documents.
• Ability to interface with external auditors.

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.
• 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 technical writing skills.
• Must be analytical and can interpret data.
• Ability to solve problems.
• Strong working knowledge of medical device quality system regulations and standards (e.g. 21CFR820, ISO 13485, ISO 14971)
• 5 years of Medical Device Quality experience preferred.

EDUCATION AND/OR EXPERIENCE:

Requires a bachelor’s degree in an Engineering discipline, or equivalent experience in a related quality role. 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. ISO 13485 Audit Certification

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 will be required to travel 25% of the time.

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.