Job Description
Job Description
TITLE: Quality Technician/ Inspector
REPORTS TO: Quality Manager
POSITION SUMMARY:
Inspection of day-to-day manufacturing through metrology equipment required for each job. Work with Quality and Engineering to ensure compliance with ISO and FDA Quality system requirements.
RESPONSIBILITIES:
· Coordinate and perform product verifications and inspections (receiving, In process, final, first article)
· Programming of the OGP measuring machine and/or CMM’s
· Support the Quality Engineer to ensure compliance with ISO 13485 and FDA 21CFR820 requirements
· Support the Process Validation process
· Support the CAPA, complaint and NCR process
· Documentation review and correction to ensure compliance with good documentation practices
· Streamline the inspection process to reduce dependence on inspection
· Special projects as required by the Quality Manager
EDUCATION AND EXPERIENCE:
Education: High school graduate
Experience:
Minimum (3) years’ experience working in an ISO or FDA regulated manufacturing environment (converting, bindery, job shop, or similar technically related industry).
Familiar with the use of various inspection equipment (dial calipers, drop gauges, etc) and the use and programming of OGP and/or CMM’s
Understanding of basic Geometric dimensioning and tolerancing and blueprint reading
COMPUTER SKILLS:
Ability to proficiently use computer and various windows programs
PHYSICAL DEMANDS:
While performing the duties of this job, the employee is regularly required to stand, walk, reach with hands and arms, and talk or hear. The employee is frequently required to lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision, distant vision, color vision and depth perception.
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.