Quality Sr Engineer II (535610)Zimmer, Inc. - Irvine, CA
Plans, directs, and performs activities concerned with the development, application, compliance, maintenance, and improvement of the quality management system, in accordance with the applicable FDA, ISO, and AATB Quality System, Medical Device, and Human Tissue regulatory standards and practices. Responsible for gathering relevant and factual information and data in order to solve quality related problems. Plan and lead projects. Develop and support a team atmosphere. Responsible for assuring products and processes conform to established requirements and standards through audit, inspection, validation, and test activities.
Principal Duties and Responsibilities
Design, execute, and manage protocols and reports for process and equipment validations. Create/write and manage IQ, OQ, PQ, Test Reports and Validation activities. Evaluate process methods and equipment to meet performance and quality requirements. Participates and contributes to product design team activities and continuous improvements projects and risk analysis. Apply ISO and QSR requirements to processes and procedures for ICI and its outside suppliers. Work with suppliers on new product introductions to insure that quality and performance requirements are fulfilled Performs core Quality Engineering functions. Conducts Internal and Supplier Audits, Create, define, and improve quality system and process procedures. Collect and Perform data analysis for Quality Performance Reporting. Assisting Manufacturing, Sourcing and Development in the interpretation and application of Quality System requirements. Manage Corrective and Preventive Actions. Investigate customer complaints. Performs root cause analysis, interfacing with Engineering, Manufacturing, Operations, Marketing, Suppliers and Customers. Supports clean room environmental monitoring, cleaning processes, and dose audit and sterilization program.
Expected Areas of Competence
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.). Ability to deliver, meet deadlines and make sound decisions. Able to communicate both orally and in written format to multiple levels of the company. Understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods Knowledge of statistics, process control, and process capability A solid working level knowledge of Excel, Word and PowerPoint. Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
B.S. in Biology, Micro-Biology, or Chemistry or equivalent experience and knowledge Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred. 7 years’ experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience. Combination of education and experience may be considered (in evaluating experience relative to requirements)
Up to 20%
8 days 11 hours ago
applyQuality Sr Engineer II (535610) Zimmer, Inc. - Irvine, CA, United States
Today, our global team of more than 8,500 employees works to provide effective, creative solutions that support orthopaedic surgeons and clinicians to
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