Quality Sr Engineer II

Zimmer Biomet seeks a Quality Senior Engineer II to lead quality engineering projects, resolve technical issues, and ensure products meet established standards. The role involves evaluating process methods, establishing quality plans, and collaborating with suppliers and internal teams. Candidates must have a Bachelor's degree in Engineering and at least 5 years of relevant experience. Proficiency in Microsoft Office, blueprint reading, geometric dimensioning and tolerancing, and knowledge of QSR/ISO regulations are required. Experience in the medical device industry and certification as a quality engineer or Reliability Engineer are preferred. The position is hybrid, requiring three days onsite in Warsaw, Indiana, with up to 20% travel.

Zimmer Biomet, a global leader in medical technology, seeks a Quality Senior Engineer II to drive quality assurance and improvement initiatives within its Warsaw, Indiana operations. This role is responsible for ensuring products meet established standards through rigorous audits, inspections, and testing. The successful candidate will collaborate with cross-functional teams, suppliers, and external experts to implement quality goals and support new product introductions. The position offers a hybrid work environment, development opportunities, and a culture of recognition. Candidates will contribute to Zimmer’s mission of enhancing patient mobility and satisfaction, while enjoying a supportive and inclusive workplace focused on innovation and professional growth.

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 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.

This is a hybrid position, 3 days onsite per week in Warsaw, Indiana.

How You'll Create Impact

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs
• Monitoring performance of processes to a standards
• Applying ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
• Developing and maintaining department and project budgets

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

What Makes You Stand Out

• 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
• Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
• Thorough knowledge base of existing Zimmer products and a basic understanding of competitive products.

Your Background

• Minimum Requirements:

Bachelor's Degree in Engineering and 5 years of relevant experience

• Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
• 5-7 years experience in a Quality Engineering role within the medical device industry strongly preferred.

Travel Expectations

Up to 20%

EOE

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

Responsibilities:

• Responsible for gathering relevant, factual information and data 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 organising activities into time-dependent sequencing with realistic timelines.
• Work effectively and 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 various functional departments, suppliers, and external experts to implement Zimmer Quality goals.
• Evaluate process methods and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes for general and specific product performance needs.
• Monitor performance of processes to standards and apply ISO and QSR requirements to processes and procedures.
• Assist Manufacturing, Sourcing, and Development in the interpretation and application of regulations.

Skills:

• Demonstrated ability to work within a team environment and build relationships with suppliers and regulatory agencies.
• Experience facilitating team efforts on quality engineering projects.
• Ability to deliver results, meet deadlines, and maintain results orientation.
• Strong oral and written communication skills across multiple company levels.
• Proficiency with 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, including use of optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability.
• Thorough knowledge base of existing Zimmer products and a basic understanding of competitive products.
• 5-7 years of experience in a Quality Engineering role within the medical device industry is strongly preferred.

Education:

• A Bachelor's Degree in Engineering is required.
• Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) is preferred.