Denver, PA 17517
Quality Control Experience in a Regulated Industry (FDA/ISO)
Under direct supervision of the Quality Assurance Supervisor and the general guidance of a Lead Inspector, performs final, first piece, and in-process inspection of purchased and in-house manufactured parts and devices. 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.
- 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. Verifies finding with Lead Inspector to ensure Company inspection standards.
- Participates in the advising of Company Management, Quality Control/Quality Assurance, Engineering, and Manufacturing Operations on quality issues and processes. May provide findings and recommendation for process improvement.
- Provides feedback to co-workers, supervisor, and Company management on a regular basis to ensure efficient and effective assembly operations.
- 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.
- 3 to 6 months previous manufacturing assembly experience with no assignable rejects.
- Demonstrated ability to read and interpret documents, instructions, and procedure manuals.
- Demonstrated oral and written communications skills to effectively interface with all levels of Company management and staff.
- Demonstrated ability to learn to read, interpret and apply statistical sampling plans.
- Demonstrated ability to perform basic mathematical functions including addition, subtraction, multiplication, division, percent, and ratios.
- Demonstrated reasoning ability to solve practical problems.
- Demonstrated ability to measure products.