Quality Engineer I

Zimmer Biomet; San Diego (CA); On-site; USD 80,000 - 95,000; Full time

Job summary

Zimmer Biomet seeks a Quality Engineer to drive quality processes across manufacturing, CAPA, NCMR, calibration, and preventive maintenance, ensuring compliance and continuous improvement.

You will lead risk-based investigations, analyze quality metrics, manage calibration programs, and support internal/external audits while developing quality procedures and SOPs to uphold a strong quality culture.

Qualifications

• B.S. in engineering or CQE certification preferred.
• 2-4 years of work experience in quality engineering or related field.
• Experience with NCMR, CAPA, root cause analysis, risk management, change control, audits, product release.

Responsibilities

• Lead NCMR and CAPA processes with root-cause investigations and timely closure.
• Analyze quality metrics and trends to identify risks and preventive actions.
• Manage Equipment Calibration and Preventive Maintenance programs.
• Support internal and external audits and corrective action follow-up.
• Develop and improve quality procedures, SOPs, and work instructions.

Skills

NCMR & CAPA leadership

Risk-based decision making

Quality metrics analysis

Regulatory awareness

Communication skills

Project management

Detail-oriented

Education

B.S. in engineering or CQE

Tools

CMMs

Optical comparators

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

The Quality Engineer serves as the process owner and technical leader for assigned Quality Engineering processes, ensuring effective implementation, compliance, and continuous improvement. The role provides Quality Engineering leadership across manufacturing and quality activities, including NCMR, CAPA, , calibration and preventive maintenance, and process improvement.

How You'll Create Impact

• Lead and/or oversee NCMR and CAPA processes, ensuring thorough and scientific based investigations identify the true root cause rather than a proximate cause, along with risk-based impact assessments, effective corrective actions, effectiveness checks, and timely closure.
• Analyze quality metrics and trends to identify recurring issues, potential product and process risks, and opportunities for preventive action and continuous improvement. Use risk-based approaches to prioritize quality issues and determine appropriate actions.
• Own and maintain the Equipment Calibration and Preventive Maintenance Program, ensuring equipment is properly calibrated, maintained, documented, and suitable for its intended use based on applicable quality and risk requirements.
• Lead or support evaluation of out-of-specifications calibration results and equipment failures, including risk-based assessment of potential impact on product quality, processes, and previously accepted product, and initiation of appropriate quality actions.
• Support the Sterilization Quality Assurance Program, including process monitoring, quality reviews, investigations, risk-based evaluation of sterilization-related issues, and annual sterilization quality review activities.
• Lead and/or participate in internal and external audits, including preparation, execution, response to findings, risk-based evaluation of audit observations, and corrective action follow-up.
• Identify and address quality system and compliance gaps, assessing associated risks and driving appropriate corrective and preventive actions.
• Develop, review, and improve quality procedures, SOPs, Work Instructions, specifications, and other controlled documents within assigned processes.
• Support regulatory and quality initiatives and promote a strong quality culture, risk-based decision-making, compliance mindset, and proactive problem-solving approach.

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.).
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Demonstrates characteristics of high potential for future development opportunities.
• Microsoft Office Suite
• Knowledge of blueprint reading and geometric dimensioning and tolerancing, basic understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and can use optical comparators and CMMs.
• Strong process ownership and leadership skills
• Highly detail-oriented and organized
• Strong analytical and critical-thinking skills
• Ability to analyze data, identify trends, and make risk-based decisions
• Strong follow-through, accountability, and time-management skills

Your Background

• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
• 2-4 years of work experience.
• Certified Quality Engineer (CQE) and Medical device is a plus
• Combination of education and experience may be considered (in evaluating experience relative to requirements)
• Experience with NCMR, CAPA, root cause analysis, risk management, change control, audits, product release, and continuous improvement.
• Experience managing or supporting equipment calibration and preventive maintenance programs

Physical Requirements

Travel Expectations

Up to 15%

Salary Expectations

$80,000-$95,000

EOE/M/F/Vet/Disability