Quality Management Systems Sr Specialist

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.

What You Can Expect

Responsible for facilitating Corrective Action Preventive Action (CAPA) investigations in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Assist in planning and fulfilling investigation tasks, implementation tasks, and verification of effectiveness tasks by identifying and organizing activities into time dependent sequencing with realistic timelines. Ensure thorough documentation of all CAPA procedural requirements. Work effectively/productively with all departments by developing a team atmosphere. Responsible for ensuring CAPA files are audit ready. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals

How You'll Create Impact

• Provides coaching for CAPA investigation from initiation through containment, root cause analysis, implementation, and verification of effectiveness.
• Provides facilitation and coaching on the problem solving process and challenges technical content.
• Interfaces with CAPA owners/teams to coach and facilitate progression through CAPA process.
• Assists with risk analysis of issue and ensures proper containment actions are applied.
• Verifies all procedural CAPA requirements are met.
• Assists to identify and escalate resource constraints/requirements, as applicable.
• Reviews CAPA files to ensure the files are audit ready, clearly tell the story, contain all required objective evidence, etc.
  
  

Other quality tasks, as requested.

What Makes You Stand Out

• Ability to work within a team environment and build relationships outside of the department
• Strong interpersonal and conflict resolution skills.
• Demonstrated CAPA experience
• Detail oriented
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• English proficiency
• Strong technical writing skills
• Microsoft Office Suite, expert knowledge of root cause analysis, and understanding of QSR/ISO regulations.
• Knowledge of statistics, process control, and process capability a plus
  
  

Your Background

• 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) a plus
• Minimum 3 years 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)
  
  

Travel Expectations

EOE/M/F/Vet/Disability

3107