New · posted Oct 15
OrthoPediatrics · Medical Devices
Post Market Quality Engineer
- Warsaw, IN
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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 Post Market Quality Engineer is responsible for medical device complaint investigations and write-ups as part of the Complaint Handling, Medical Device Reporting and Vigilance Reporting process. This position will ensure timely, accurate, and complete failure investigations, root cause analyses, risk analyses, and other complaint-related tasks are performed and documented for product field failures.
What you need
What you'll do
- Work within cross-functional internal and external teams to investigate device field complaints and provide solutions to resolve complaints in a timely manner.
- Perform failure analysis of medical devices using various types of test equipment, fixtures, and software tools.
- Utilize applicable quality tools (Root cause analyses) to ensure timely, accurate, and complete failure investigations of product complaints leading to the root cause and ensure that all activities are documented in the complaint management system.
- Review internal and external documentation such as device history records, material certifications, inspection reports, and any additional supporting documentation for conformance for complaint investigations.
- Comply with Quality Management’s guidance and instruction and provide complaint status updates.
- Work with Product Line Engineers to complete post market risk assessments and drive periodic updates to risk management documentation and potentially other documents.
- Develop, update, and maintain Job Aids and Work Instructions to facilitate and standardize investigation activities.
- Ability to interface with external auditors.
SUPERVISORY RESPONSIBILITIES
There are no supervisor responsibilities with this position.
- Thorough knowledge of specifications, dimensions, tolerances, and GD&T.
- Ability to work in a strong team environment and/or independently while being self-motivated and having self-direction.
- 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)
- ISO 13485 Audit Certification preferred
- 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.
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.
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 5% 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.
Where you'll work
Warsaw, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Warsaw, INEqual opportunity, accessibility and legal noticesOrthoPediatrics's statements, word for word
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.)
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.)
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.)
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Indiana13 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Indiana (middle half) | $117,000 | $117,000 | $119,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not OrthoPediatrics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs7
- Investigations and CAPA6
- GMP and compliance5
- Lab testing and methods4
- Quality systems and risk4
- Data and digital systems3
- Collaboration and leadership3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
OrthoPediatrics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Post Market Quality Engineer at OrthoPediatrics
Open until filled.