Principle Quality Engineer

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.

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

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

• 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

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

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.

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.