A Senior QC Inspector is proficient in performing all duties and responsibilities of QC Inspector I and II, assists the QC Lead in reviewing of device history record to assure compliance and assists in training of other QC Inspectors.
Assists the Receiving Inspection Supervisor in the preparation of pre- and post- sterilization and of the release of product to Finished Goods.
Performs quality inspection functions during development phases of new products / projects.
Performs and documents QC inspection activities to assure conformance to specification and procedural requirements
Provides feedback to QA, Operations and R&D on quality issues
Assists product development team members in inspection of new product development and / or product changes
Assists the line lead in training other QC Inspectors
Assists QC Lead in reviewing and closing Build Records
Assists Receiving Inspection Supervisor in the preparation of product for pre-sterilization and in inspection of product post-sterilization
Performs special projects as directed
Demonstrated knowledge of inspection techniques; understanding and reading technical documentation including mechanical drawings
Good written and oral communication skills
Working in controlled environments (clean rooms)
Good interpersonal skills
Knowledge of GMP (QSR) and / or ISO regulations
Knowledge of computer software, including Microsoft Word and Excel
Ability to work in a fast-paced environment and to balance and prioritize work load to support production schedule
Ability to perform Quality performance testing for product release into Finished Goods
Minimum 5 years in quality control for medical device manufacturing
Previous experience with video inspection equipment and other inspection tools required
Experience with inspection sampling plans
High School diploma or equivalent