?Follows all Good Manufacturing Practices, Quality System requirements and company procedures ensuring quality and regulatory requirements are met in an ethical manner.?Perform inspections of purchased parts, subassemblies and/or finished company products according to defined criteria in product documentation (drawing, specification, procedures, or build packages) by visual inspection and/or using standard physical and/ or mechanical measurements, according to procedures and in a timely manner.?The Quality Control Specialist is responsible to correctly complete all required documents. One of the responsibilities of this position is verify and ensure accuracy of the data, during the procedure process and at the end of each Lot, ensuring the accuracy of records and maintaining supporting documentation. ?Complete the required documentation and certification in a timely manner and with a high level of attention to detail to help ensure product is shipped by their due dates?Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices.?Create the appropriate Certificate of Conformance documents based on the lot history reviews and customer requirements.?Proficient in all quality processes and procedures according to the training matrix.?Collect samples from manufacturing and ship for outside testing purposes?Conduct environmental monitoring where required.?Manage the Quarantine cage activities; verify containment of nonconforming material when needed.?Participate in the construction and/or revision of SOPs for the inspection function.
1-4 years
Evaluate problems and make initial recommendations for possible corrective action to the Quality Manager.--Identify and communicate defects or suspect materials to the Quality Manager in a timely manner.--Work with Production Management and Quality Assurance to provide feedback to assemblers regarding accuracy of assembly procedures.--Maintain order and cleanliness of Quality stations to prevent material mixing.--Maintains a safe and healthy work environment by implementing, maintaining and aligning company policies and procedures.--Correct use of resources of the company such as materials, machines, time and others.--Active member of the continuous improvement team.--Present their area results, plans and improvements when requested.--Participate and assist as a part of the Internal Audit team where appropriate and as requested.--Support Document Control and record management as required.--Other duties as assigned, verbal and written.
?High School Diploma or equivalent.?2+ year of previous experience as in process, incoming or outgoing inspector is preferred.?One year minimum in Medical Devices Industry (Desirable).?Working knowledge of measurement instruments.?Knowledge of Quality Systems documents and general Good Documentation Practices.
High School
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