Principle Quality Engineer

NIPRO Corporation - Global; Lewisberry (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Nipro Medical Corporation is seeking a Principal Quality Engineer to lead quality systems, CAPA, and regulatory compliance at our Lewisberry, PA site. You will partner with Operations, Regulatory Affairs, and Product Development to drive quality excellence and patient safety.

The role focuses on CAPA leadership, audits, and continuous improvement using Lean Six Sigma methodologies, impacting product quality and site performance.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical discipline.
• 8–10+ years of Quality Systems experience within the medical device industry.
• Experience supporting medical device manufacturing operations in a regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and quality management systems.
• Proven success leading CAPA investigations, validations, and continuous improvement initiatives.

Responsibilities

• Lead and facilitate the site CAPA Review Board.
• Drive quality system compliance and support FDA, ISO 13485, and MDSAP requirements.
• Ensure inspection readiness and support regulatory, customer, and internal audits.
• Lead and support CAPA investigations, root cause analysis, and corrective actions.
• Analyze quality and production metrics to identify trends and implement improvements.
• Drive continuous improvement initiatives utilizing Lean and Six Sigma methodologies.
• Review and approve quality records, validation documentation, engineering changes, and quality plans.
• Mentor Quality Engineers and provide regulatory guidance to cross-functional teams.

Skills

Quality Systems

CAPA

Regulatory Compliance

Lean Six Sigma

Risk Management

Education

Bachelor's degree in a scientific or engineering field

Tools

FMEA

NCMR

Control Plans

Process Capability

Audit Management

Job description

Are you a quality leader who thrives in a highly regulated medical device environment? We are seeking a Principal Quality Engineer to provide quality systems, CAPA, and compliance leadership at our Lewisberry, Pennsylvania manufacturing facility. This role offers the opportunity to make a significant impact by driving quality excellence, regulatory compliance, and continuous improvement initiatives that directly support product quality and patient safety.

What You'll Do

As a Principal Quality Engineer, you will serve as a key partner to Operations, Manufacturing Engineering, Regulatory Affairs, Supply Chain, and Product Development teams while providing technical leadership across the site.

Key responsibilities include:

• Lead and facilitate the site CAPA Review Board
• Drive quality system compliance and support FDA, ISO 13485, and MDSAP requirements
• Ensure inspection readiness and support regulatory, customer, and internal audits
• Lead and support CAPA investigations, root cause analysis, and corrective actions
• Analyze quality and production metrics to identify trends and implement improvements
• Drive continuous improvement initiatives utilizing Lean Manufacturing and Six Sigma methodologies
• Review and approve quality records, validation documentation, engineering changes, and quality plans
• Partner with Manufacturing and Operations to improve product quality, process capability, and operational performance
• Facilitate risk management activities and quality engineering best practices
• Mentor Quality Engineers and provide regulatory guidance to cross-functional teams
• Lead strategic quality improvement projects and influence site quality strategy through data-driven decision making

Qualifications

Required

• Bachelor's degree in a scientific, engineering, or related technical discipline
• 8-10+ years of Quality Systems experience within the medical device industry
• Experience supporting medical device manufacturing operations in a regulated environment
• Strong knowledge of FDA Quality System Regulations, ISO 13485, and quality management systems
• Proven success leading CAPA investigations, validations, and continuous improvement initiatives

Preferred

• Master's degree in quality, Engineering, or related field
• ASQ Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)
• Lean Six Sigma Green Belt or Black Belt (LSSGB/LSSBB)
• Lead Auditor certification
• Experience supporting Class II and/or Class III medical devices

Technical Expertise

We are looking for strong experience in:

• Quality Systems Management
• CAPA Programs
• Nonconforming Material Reports (NCMR)
• FMEA
• Process Capability Analysis
• Control Plans
• Lean Manufacturing
• Six Sigma Methodologies

Why Join Us?

At Nipro, quality is at the center of everything we do. This role offers the opportunity to influence site-wide quality strategy, mentor future leaders, and help drive operational excellence in a growing medical device manufacturing environment.

If you are passionate about quality, compliance, continuous improvement, and making a meaningful impact in healthcare manufacturing, we'd love to hear from you.

Nipro Medical Corporation is an Equal Opportunity Employer.

We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, protected veteran status, citizenship status, or any other characteristic protected by federal, state, or local law.

We are dedicated to fostering an inclusive workplace where all individuals are treated with respect and dignity and have the opportunity to contribute to the success of the organization. Employment decisions are based on qualifications, merit, business needs, and performance.

Reasonable accommodations may be made to enable qualified individuals with disabilities to participate in the application process and perform the essential functions of the job.