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.

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.
• Excellent verbal and technical writing skills.
• Analytical and can interpret data.
• 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).

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.
• 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

• 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.