Description:
POSITION SUMMARY:
The Quality Inspector will provide quality control and assurance throughout all phases of the production process beginning with raw materials and ending with the final product. (Incoming, in-process & final inspection). Occasionally work overtime on weekends, as needed.
ESSENTIAL FUNCTIONS:
-
Receiving inspection of raw materials, sub-assemblies and label copy
-
In-process and final inspection of work orders, sub-assemblies and final packaged goods
-
Perform First Article Inspections
-
QA documentation filing (DHR records, etc.)
-
Review and approval of all associated documentation
-
Inspection of OEM & customer documentation packages
-
Interface with suppliers to resolve discrepancies, seek approval and certification status
-
Support continuous improvement activities
-
Assist in customer complaint investigation
-
Maintain calibration and retain records
-
NCR creation/closures
-
Other duties as required
Requirements:
QUALIFICATIONS, SKILLS, ABILITIES REQUIRED:
-
Possess mechanical/technical aptitude; ability to read and interpret blueprints/inspection plans.
-
Knowledge of standard mechanical measuring tools and apparatus, including calipers and optical comparators.
-
Understanding of inspection and sampling techniques
-
Excellent verbal and written communication skills.
-
Ability to maintain close attention to detail and accuracy.
-
Solid computer literacy and data entry: proficient in Microsoft Office Suite or related software as needed to complete reports.
-
Understanding of medical device industry standards- ISO 13485 and FDA GMP.
-
Ability to meet inspection and manufacturing time restraints.
-
Ability to lift 50 lbs.
EDUCATION, EXPERIENCE REQUIRED:
-
High School diploma (technical school preferred)
-
Minimum of 3 to 5 years of Quality and/or Manufacturing experience
