About the position
The Technician Quality Assurance IV Coordinator at Ethicon Inc. is a senior support individual contributor role focused on ensuring quality control within the manufacturing process. This position involves coordinating various quality assurance activities, managing documentation, and participating in the development of testing and inspection procedures. The role requires a proactive approach to quality management, including leading improvement initiatives and supporting audits and inspections.
Responsibilities
? Coordinate administrative, interpersonal, testing methodologies, and inspection support activities for the Quality department.
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? Perform Quality Operations and maintenance tasks and participate in developing new testing and inspection procedures.
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? Supervise and maintain documentation of quality tests, audits, and inspections in accordance with regulatory and organizational requirements.
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? Assure optimum control of quality for raw material and tooling inspection and/or finished products in accordance with existing requirements.
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? Manage quarantine cages and recommend amendments to sampling procedures and test methods.
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? Use document change control system to build, modify or revise Standard Operating Procedures (SOPs).
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? Perform quality walkthroughs and non-conformance investigations for CAPA and internal audit observations.
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? Lead Kaizens and Proactive Quality activities for overall improvements from a Quality Assurance perspective.
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? Support internal and external audits and inspections.
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? Complete training programs and certifications as required.
Requirements
? A minimum of a High School diploma, G.E.D. or equivalent required.
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? A minimum of six (6) years of related Quality Assurance experience in a regulated environment is preferred.
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? Proficient in the preparation of technical reports and presentations.
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? Knowledge of Microsoft Word, Excel, and Outlook required.
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? Knowledge of SAP, Laboratory Information Management Systems (LIMS), and ADAPTIV required.
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? Strong communication, interpersonal, and influencing skills are essential.
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? Strong analytical problem-solving skills and self-motivated with limited supervision.
Nice-to-haves
? Associates degree in engineering or a related technical discipline is preferred.
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? Knowledge of Good Manufacturing Practices (GMPs) preferred.
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? Experience with investigation tools (e.g. DMAIC, Fishbone Analysis, 5 Whys) preferred.
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? Knowledge of statistical data analysis tools (e.g. Minitab) preferred.
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? Experience in the QSR/ISO regulated Medical Device industry is preferred.
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? Knowledge of Process Excellence/Six Sigma concepts/tools is preferred.
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? ASQ certification is preferred.
Benefits
? Diversity, equity, and inclusion initiatives
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? Career development programs
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? Health and wellness support programs
