Inspection Quality Technician

GENERAL SUMMARY: The Inspection Quality Technician provides hands-on expert technical support for product quality inspection related functions, inspection test method development, and product acceptance activities. In addition, this position will support the assembly of medical device surgery trays/kits as needed.

ESSENTIAL FUNCTIONS:

• Assist in the development, implementation, and monitoring of product quality inspection requirements.

• Perform product inspection activities to ensure conformance to product specifications.

• Assist in the development and maintenance of product quality inspection related SOPs and Work Instructions.

• Participate in CAPA activities.

• Assist in MSA and Gauge R&R studies.

• Act as subject matter expert for daily operations quality functions.

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.)

• Ability to work in a strong team environment.

• Detailed knowledge of non-destructive product testing/inspection techniques.

• Skilled in the use of a variety of inspection and metrology equipment such as micrometers, calipers, optical comparators, go no-go gauging, and others.

• Must have prior experience developing and maintaining product quality inspection related SOPs and Work Instructions.

• Must have excellent verbal and written communications skills.

• Detailed knowledge of GD&T and the ability to accurately interpret part drawings/prints.

• Ability to solve problems.

• Strong working knowledge of medical device quality system regulations and standards including, but not limited to, 21CFR820, ISO 13485, EU MDR.

EDUCATION AND/OR EXPERIENCE: Minimum of 3 years of inspection experience in the medical device field. Knowledgeable in gauging methods and their applications, as well as product inspection. ASQ certification preferred. Must have computer skills (Microsoft Office).

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.

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 occasionally performs work related to travel.

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.