Zimmer Inc.
Quality Sr Engineer I (615818) (Architecture)
Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.
Formulates procedures, specifications, and standards for Zimmer products and processes. Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance. Develops and implements corrective/preventative action plans Collects and analyzes data for gauge and product evaluation. Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products. Assesses and determines validation and verification requirements for Supplier Change Notifications, and drive the Supplier Change Notifications to completion. Performs supplier Desktop Assessments and Supplier Onsite Audits. Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer.
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.). Facilitates team efforts on quality engineering projects. Ability to deliver, meet deadlines and have results orientation. Able to communicate both orally and in written form to multiple levels of the company. Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs. Knowledge of statistics, process control, and process capability Ability to Lead and Perform Suppliers Audits without supervision.
B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE). Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred Certification as a Lead Auditor for ISO 13485:2016. Minimum 3 year's experience in a Quality Engineering role, 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%