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.

• 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.

Therearenosupervisorresponsibilitieswiththisposition.

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. 21
  
  CFR
  820, ISO 13485, ISO 14971)
• ISO 13485 Audit Certification preferred
• 5 years of Medical Device Quality experience preferred.

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.

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.

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

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.

Requires a valid driver’s license. ISO 13485 Audit Certification

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.

(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…