Job Description

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.

What You Can Expect

The Quality Engineer II has varied responsibilities to assist the Quality team in ensuring compliance to regulations and standards. They take a lead role in MRB management, incoming inspection technical expertise, CAPA investigations and continuous improvement projects. A QEII will be expected to take initiative and demonstrate inquisitive approaches to solve moderately complex problems, generate alternatives and recommend solutions.

How You'll Create Impact

• Support production activities from a quality standpoint, utilizing problem solving tools and techniques and applying risk-based approaches.
• Evaluate and develop effective and efficient methods for the inspection of products, as well as providing technical support to incoming inspections.
• Maintain an effective and complaint Calibration program
• Design, validate and maintain quality management system software.
• Perform quality data trending and leads/supports process improvement initiatives.
• Draft and execute equipment validations
• Manage and complete Corrective and Preventative Actions including Identification, Risk Analysis, Investigation and Root Cause Analysis and Implementation.
• Own and lead projects for improved business efficiencies with a Lean/Six Sigma mindset of understanding problems, improving, and controlling outcomes.
• Responsible for MRB activities including but not limited to NCR generation, investigation, disposition and closure.
• Guide and mentor Quality Engineer I's and Associate Quality Engineers
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Other duties as assigned.

Your Background

• Bachelor's in Engineering or technical discipline and 3 years of related experience
• Medical device experience preferred
• Process Validation experience preferred
• Calibration experience preferred
• Gage R&R experience preferred
• Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards
• Strong computer skills (MS Word & Excel)
• Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques.
• Technical knowledge in development methodologies, design, project implementation, including, but not limited to GD&T, DOE, verification, and validation.
• Experience reading and interpreting part drawings/GD&T
• Knowledge and use of measuring equipment preferred.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Recognized process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training preferred.
• Knowledge and use of Quality Management software applications
• Knowledge and use of relevant statistical and other software applications and skills to use them effectively for data analysis.

Travel Expectations

Up to 10% overnight travel

Compensation Data

Annualy Salary Range: $70,000 - 90,000 USD

EOE

Job Tags

Full time, Night shift,

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