Quality Senior Engineer II

Full Time
Warsaw, IN 46580
Posted
Job description

Requisition Number

AMER27907

Employment Type

Full-time

Location

Warsaw
Job Summary
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. This position provides administrative support to an executive leader and may also support other leadership team members. Success involves a high level of interaction and required effective communications with senior leaders and team members at all levels of the organization. May also include communications with surgeons and distributors. A significant portion of the job involves planning, coordinating and making domestic and international travel arrangements that are frequently subject to last minute changes.
Principal Duties and Responsibilities
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. Evaluates process methods and equipment to meet performance and quality requirements. Establishes quality plans for equipment and processes for general and specific product performance needs. Monitors performance of processes to a standard. Applies ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers. Works with suppliers on new product introduction to ensure that quality and performance requirements are fulfilled. Assists Manufacturing, Sourcing and Development in the interpretation and application of regulations. Develops and maintains department and project budgets.
Education/Experience Requirements
Requires a Bachelor's degree in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology or related field and 3 years of experience in an engineering role or related position.
Must have 6 months of experience in the medical device industry. Must have 2 years of experience with the following: design engineering experience; preparing documentation for medical device design control including Design History File (DHF) or Risk Management Files (RMF); and working in a cross functional team environment as project lead interfacing with other development personnel, quality engineers, manufacturing engineers, packaging engineers, and regulatory and clinical affairs personnel.
Travel Requirements
Up to 50% domestic travel for employees working with suppliers.

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