Lead, Receiving Inspection - CR
Position Overview
Responsible for leading a group of QC inspectors. Support the inspection of received materials or finished product. Prepare Nonconformance Reports. Communicate with QA management, Engineering, and Operations as needed to facilitate effective inspection and manufacturing. Perform other duties as assigned by management. Job duties:
- Support QC Inspectors in their inspection activities.
- Set inspection priorities and ensure delivery of material on time to the production floor.
- Prepare Nonconformance Reports and other documentation.
- Provide input to QA Management.
- Communicate with Engineering and Operations as needed to report issues and to improve and maintain high quality levels.
- Provide QC support to Engineering for product development and product improvement projects.
- Ensure product release testing is completed prior to releasing product to finished goods.
- Ensure product pre- and post-sterilization activities are completed prior to releasing product to Finished Goods.
- Assist in the training of QC Inspectors to documented procedures.
- Prioritize workload based on production requirements for QC Inspectors.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- High School diploma or equivalent.
- Minimum three (3) years of experience in quality control for medical device manufacturing.
- Experience working in controlled environments areas (CEA).
- Knowledge of technical design drawing interpretation and raw material inspection requirements.
- Knowledge on regulations and GMPs.
- Knowledge of computer software, including Microsoft Word, Excel, and outlook.
- Strong written and verbal communication skills.
- Knowledge of inspection sampling plans and standards.
- Ability and willingness to work overtime when required.
- Ability to understand supplier documentation (e.g., certification of conformance, material, MSDS etc.).
- Understanding of basic metrology.
- 60% English required.
- Ability to read and prepare technical documentation.
- Ability to use a microscope and other inspection equipment or tools to examine components, materials and/or product/assemblies.
- Ability to promote effective working relationships at all levels and create a positive work environment.
- Knowledge of medical product manufacturing and quality.