Post Market Quality Engineer

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

Job summary

OrthoPediatrics Corp. in Warsaw, IN, seeks a Post Market Quality Engineer to lead medical device complaint investigations and write-ups as part of the Vigilance process. You will ensure timely failure analyses, root cause determinations, and risk assessments are documented and compliant with regulatory standards.

The role requires collaboration with cross-functional teams, strong analytical skills, and experience with quality systems and regulatory requirements for medical devices.

Qualifications

• Bachelor’s degree in an Engineering discipline or equivalent experience in a related quality role. ASQ certification preferred.
• Must have computer skills; MS-Excel.

Responsibilities

• Investigate device field complaints and provide timely solutions.
• Perform failure analysis of medical devices using test equipment and software tools.
• Apply quality tools (Root cause analyses) to ensure complete investigations and documentation in the complaint system.
• Review device history records, material certifications, inspection reports and related documents for conformance.
• Provide complaint status updates following Quality Management guidance.
• Collaborate with Product Line Engineers on post market risk assessments and update risk management documents.
• Develop, update and maintain Job Aids and Work Instructions to standardize investigations.
• Interface with external auditors.

Skills

GD&T

Root cause analysis

Statistical methods

Quality systems

Documentation

Teamwork

Communication

Education

Bachelor’s degree in Engineering

Tools

MS Excel

Quality management software

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:

Therearenosupervisorresponsibilitieswiththisposition.

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.)

• 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:(