SUMMARY OF POSITION:
Reporting directly to a Quality Engineer, this position is responsible for the acceptance/rejection of raw materials and manufactured product that includes the production of subassembly and finished products based on product specifications and procedures. This position maintains quality and reliability of products approved for distribution by performing the following duties.
ESSENTIAL FUNCTIONS AND ACCOUNTABILITIES:
1.Responsible for seeing that all tasks are performed in a manner that complies with Cardinal and the Chicopee facility Total Quality Management commitment.
2.Testing includes using documented procedures and various inspections and testing equipment. Results are recorded on appropriate data sheets as designated by the established inspection and sampling plans. Includes approving raw materials, start-ups and final pack inspections. Reviewing and approving products for conformance to defined specifications and inspection requirements prior to release is also required.
3.Sets up test apparatus and conducts tests of products while following methods, procedures, standards, and sequences. Uses equipment that is calibrated and maintained. Troubleshoots and performs routine maintenance on laboratory instrumentation.
4.Issues necessary specifications, samples, retains and other documentation required by manufacturing to support the production schedule (Job Jackets).
5.Making immediate on-site decisions regarding product quality including implementing the nonconforming product and Material on Hold systems. This includes placing product on physical and electronic hold and notifying the appropriate Quality Engineer that a Material Review Board (MRB) may be needed to determine disposition of nonconforming product. Recommends root cause and corrective action for Material on Hold.
6.Data entry for test results and data into data collection systems. May include approving relevant data including the completeness of the Device History Record (DHR).
7.Assists with the investigation of customer complaints and CAPAs to determine the root cause and helps to implement corrective/preventive action(s) for elimination of the root cause.
8.Follows written directions/instructions issued by Quality Manager, Quality Engineer or Focus Factory Leader
9.Maintains equipment within assigned area, including making basic repairs as needed or directed.
High School diploma or Bachelor's degree preferred
2 to 4 years related Quality experience preferred; 2 to 4 years Medical industry or device manufacturing experience preferred.
Experience in a GMP environment is preferred. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence. Ability to communicate effectively and routinely across many departments. Working knowledge of FDA Quality System Regulations, applicable Quality System Standards and Regulations and facility Safety requirements.
Ability to perform routine mathematical operations using whole numbers and decimals. Ability to calculate rates and percentages, and interpret basic graphical data.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving general concrete variables in standardized situations. Must have the ability to accept and work with constant change.
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.