348 N Reading Road Denver, PA 17517
Under limited supervision of the Quality Assurance Manager, performs final, first piece, and in-process inspection of purchased and in-house manufactured parts and devices. Performs DHR reviews. Ensures that all parts and devices inspected conform to engineering and manufacturing specifications and standards.
- Selects product samples to perform final, first piece, and in-process inspection of purchased and in-house manufactured parts and devices for medical and OEM devices and pharmaceuticals using instruction sheets, specification sheets, and product drawings to determines product acceptability.
- Performs Device History Record (DHR) Reviews per company standard operating procedures.
- Works with appropriate RML and/or supplier personnel to resolve documentation and records issues with incoming purchased product.
- Using a variety of gauges, measuring equipment, and visual acuity, inspects first pieces, in-process parts, finished parts to ensure that manufacturing equipments has been correctly set-up and calibrated to meet engineering and manufacturing specifications and standards.
- Advises Company Management, Quality Control/Quality Assurance, Engineering, and Manufacturing Operations on quality issues and processes. When necessary, provides findings and recommendation for process improvement.
- Provides feedback to co-workers, supervisor, and Company management on a regular basis to ensure efficient and effective operations.
- Notifies management of quality issues or inspection scheduling priorities that may affect production capabilities or capacities.
- May be designated as the “key person” providing limited guidance and direction for a specific process.
- Actively participates and adheres to Company policies and programs on occupational health and safety, good manufacturing practices (GMP), and ISO procedures.
- 1st Shift
- Monday - Friday
- Must have experience in a FDA Regulated Experience