Senior Quality Engineer

Zimmer Biomet; Warsaw (IN); On-site; USD 89,000 - 112,000; Full time

Job summary

Zimmer Biomet in Indiana seeks a Quality Engineer to gather factual data, solve quality problems, and lead projects from planning to execution. You will assure products conform to established requirements through audits, inspections, and test activities while coordinating with manufacturing, sourcing, and development teams.

The role emphasizes applying QSR/ISO requirements, statistics, FMEA, and process capability to improve quality.

Qualifications

• B.S. in engineering or equivalent with CQE certification.
• 5–7 years in a Quality Engineering role; medical device experience preferred.
• CQE or CRE certification preferred.
• Education and experience may be combined and evaluated.

Responsibilities

• Evaluate processes and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes.
• Monitor process performance to standards.
• Apply ISO and QSR requirements to processes and suppliers.
• Collaborate with Manufacturing, Sourcing and Development on regulations.
• Support supplier involvement for new product introductions.

Skills

Blueprint reading

Geometric Dimensioning & Tolerancing

QSR/ISO knowledge

FMEA

Design assurance

Statistics

Process control

Process capability

Team facilitation

Microsoft Office

Education

B.S. in engineering or equivalent

CQE or CRE certification

Tools

Optical comparators

CMM

Job description

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 talent 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 included, respected, empowered and recognised.

What You Can Expect

In this role you will be responsible for gathering relevant, factual information and data in order to solve quality related problems. You will resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. You will also plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. You will also play a key role in assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities while interacting with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.

How You'll Create Impact

• You will evaluate process methods and equipment to meet performance and quality requirements

• You will establish quality plans for equipment and processes for general and specific product performance needs

• You will monitor performance of processes to standards

• You will apply ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers;

• You will work with suppliers on new product introduction

• You will assist Manufacturing, Sourcing and Development departments in the interpretation and application of regulations

What Makes You Stand Out

• You have 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 CMM

• You have 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

• You have knowledge of statistics, process control, and process capability

• You can facilitate team efforts on quality engineering projects

• You are comfortable using Microsoft Office Suite

Your Background

• You have B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE)

• You have 5-7 years experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.

• You have certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.

• Combination of education and experience may be considered (in evaluating experience relative to requirements)

Travel Expectations

• Up to 20% (up to 50% if working with Suppliers)

Expected Compensation - $89,000–$112,000 base salary, plus performance bonuses

EOE/M/F/Vet/Disability