About this role
• Supports the operations of the Quality Control department in adherence to FDA 21 CFR, ISO 13485 and GMP regulations. • Performs routine inspections as assigned on materials, in-process or finished products where results are compared to company quality standards. • Performs visual and functional inspections on in-process and finished product. • Perform audits on products at various stages of the manufacturing process. • Notifies designated supervisor/quality engineer when inspection results exceed acceptable limits and/or reports major quality incidents. • Performs tasks using good cleaning practices and safety techniques. • Work in liaison with production, engineering and quality engineering. • Perform other duties or assignments as required by management or assigned supervisor.
• Skill and accuracy required to operate measuring instruments and test equipment. • Ability to review and understand written instructions, including drawings, specifications and method sheets. • Knowledge of GMP's or DHR's and Good Manufacturing Practices. • Communication skills. • Ability to multi-task in a fast-paced environment. • Basic computer skills. • Ability to see 20-20, or corrected vision.
Work Environment: • Accelerated environment Experience: • Quality related experience desirable. Education: • Secondary Education degree is desirable or 9th Secondary grade plus Quality Inspector/Technician certification.. • Basic English level is a plus.