QA Inspector

Quality Assurance SpecialistResponsible for the implementation of the quality assurance program as it relates to non-conforming products and raw materials ensuring quality system requirements and standards are met including FDA, ISO and MDD requirements.Key Responsibilities•Performs root cause analysis on non-conforming, products and processes defects for continuous improvement•Performs inspection of rejected components, sub-assemblies and finished products and prepares Material Rejection and Purge Reports for non-conforming material trending.•Responsible for preparing protocols, coordinating and performing data collection and analysis for process and product validation studies.•Assists with the calibration program for all test and measurement equipment and maintaining the Calibration Log and applicable Calibration Records.•Responsible for monitoring and maintaining a quality environment compliant with all applicable quality and regulatory requirements.•Cross-trained to perform all quality inspection and receiving inspection positions to include inspect and release sterilization loads, reconciliation of sterilization loads and in-process and final inspection in both Converting and Packaging departments.•Test returned consumer samples to resolve customer complaints.•Document results of tests, analyses in accordance with good laboratory practices (GLP).•Cross-trained in various QA Supervisory functions to include employee training on FDA, ISO and MDD requirements and handling customer complaints.•Assists with data entry, review of work orders and filing completed work orders.•Assists QC Supervisor with special projects as required•All employees have the responsibility and authority to report any action that puts any process or product at risk.•Other duties as assignedQualificationsTo perform this job successfully, an individual must be able to perform each essential duty/key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EducationHigh school diploma or equivalent preferred.Experience2+ years previous QA experience in a manufacturing environment preferred.Skills & AbilitiesAble to speak, read, and write in English; and possess basic math competencies (add, subtract, multiply, and divide). Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Must be computer literate, able to proficiently use MS Office, and Outlook. Prior use of MRP systems highly required. Must be detail oriented, possess sound communication skills both written and verbal, and able to work a flexible schedule. Able of standing for a full shift (8 to 12 hours); able to lift, push, pull up to 50+ pounds; and walk, stoop, kneel, bend over, and grasp objects with both hands on a frequent basis. Visual acuity or corrective vision required for this position including close vision, distance vision, and color vision. Possesses initiative, common sense and analytical problem-solving characteristics. Demonstrates willingness and ability to be cross-trained in other QA job functions. Ability to report to work on time on a consistent and regular basis. Ability to speak, read, and write in Spanish a plus.