Quality Senior Engineer II

1 week ago

Warsaw, United States Zimmer Biomet Full time

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging. DUTIES The Quality Senior Engineer II will be 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; interact with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer quality goals Requirements - Education and Experience Education Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related field. Experience Must have 5 years of experience in job offered or a related position. Must have 3 years of experience in the following: FDA regulated industry experience; total engineering project experience including leading CAPA Process Using DMAIC methodology, root cause analysis utilizing efficient root cause tools, and experience with project management tools such as Gantt chart, Project Burn down charts; risk Determination; FMEA Analysis; performing product and process containment activities; process and Product Non-conformance investigations; developing feasible and impactful solutions; and Verification of effectiveness planning. Must have 2 years of experience with the following: Applying statistical analysis for quality control/assurance and CAPA Verification of Effectiveness plan (Statistical based sampling, Capability Studies, Null Hypothesis Testing, Design of Experiments (DOE); preparing, Reviewing and approving CAPA Metrics and Quality system records in a manner complaint with 21 CFR Part 820 & part 11 regulations and ISO13485; ability to Demonstrate leadership and lead team meetings; ability to influence people with decisions and make critical quality decisions; Interviewing and Onboarding new Team members; create CAPA Training material and Coach team members across organization on the training material; ability to lead Kaizen event, CAPA Review Board meetings and internal audits; and ability to lead quality Circles. Must have experience with the following: ISO quality systems auditing; Presenting to a non-technical audience; Providing training to a technical audience; and Lean Manufacturing projects. Travel Expectations Telecommuting work arrangement permitted: position may work in various unanticipated locations throughout the U.S. Remote work permitted up to 5 days per week throughout the U.S. Up to 50% of domestic travel required. LOCATION: Biomet Manufacturing, LLC (formerly Corp.), 56 E Bell Drive, Warsaw, IN 46582 EOE/M/F/Vet/Disability

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