Post Market Quality Engineer

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 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.)

• 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: (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 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.