Principal Quality Compliance Engineer – Medical Devices

New World Medical Inc; Rancho Cucamonga (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) with Profit Share

Bonus Opportunities

Career Development Program

Tuition Assistance (after 1 year of服务)

Cell Phone Stipends

Wellness & Employee Assistance

Job summary

New World Medical Inc., a mission-driven ophthalmic device company, seeks a seasoned Quality/Regulatory Compliance professional to ensure product and quality system compliance. You will drive CAPA responses, regulatory gap assessments, and audits with cross-functional teams.

The role focuses on maintaining standards alignment with CAPAs, regulatory audits, and continuous improvement of QMS processes across product lines. Strong leadership and documentation skills are essential.

Qualifications

• Bachelor’s Degree in Engineering, Life Science or closely related field or equivalent experience
• Minimum 8 years in Quality or related field
• Experience in standard review and product testing per standard requirements preferred

Responsibilities

• Create and maintain documentation to ensure product and quality system compliance with recognized standards
• Manage compliance target lists and lead gap assessments for changes to product compliance
• Collaborate with Engineering to determine applicable standards and document required validation activities
• Review and revise product documentation to maintain regulatory targets
• Lead process or procedure improvement projects to sustain QMS compliance
• Support third-party and regulatory audits (MDSAP, ISO 13485, MDR)

Skills

Team leadership

Regulatory knowledge

Project management

Documentation

Communication

Quality systems

Education

Bachelor's Degree in Engineering or Life Science

Tools

MS Word

MS Excel

Outlook

PowerPoint

Visio

Job description

New World Medical Inc., a mission-driven ophthalmic device company, seeks a seasoned Quality/Regulatory Compliance professional to ensure product and quality system compliance. You will drive CAPA responses, regulatory gap assessments, and audits with cross-functional teams.

The role focuses on maintaining standards alignment with CAPAs, regulatory audits, and continuous improvement of QMS processes across product lines. Strong leadership and documentation skills are essential.