Post Market Quality Engineer

OrthoPediatrics Corp.; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

OrthoPediatrics Corp. is seeking a Post Market Quality Engineer in Warsaw, Indiana. In this role, you will be responsible for medical device complaint investigations, ensuring compliance with regulatory standards, and working collaboratively with cross-functional teams.

The ideal candidate should have a bachelor’s degree in Engineering or related quality experience and a solid background in medical device regulations. This position requires analytical thinking and a strong knowledge of quality tools and quality systems.

Qualifications

• Minimum 5 years of Medical Device Quality experience preferred.
• ISO 13485 Audit Certification preferred.
• Thorough knowledge of medical device quality system regulations.

Responsibilities

• Conduct failure analysis of medical devices.
• Investigate device field complaints with dedicated teams.
• Ensure timely and accurate documentation of complaint investigations.

Skills

Specifications and Tolerances

Teamwork

Statistical Applications

Analytical Skills

Problem Solving

Medical Device Regulation Knowledge

Education

Bachelor’s degree in Engineering

Tools

MS-Excel

Statistical Process Control (SPC)

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 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.

Essential Functions

• 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 arenosupervisorresponsibilitieswiththisposition.

Qualifications

• 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.

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 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.