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

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