Lead Quality & Regulatory Compliance Engineer (Medical Devices)

Regulatory Jobs; Rancho Cucamonga (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

New World Medical in Rancho Cucamonga, CA is seeking a Compliance/QA Manager responsible for ensuring product compliance to testing and regulatory standards, leading improvement projects, and supporting audits.

You will collaborate with engineering, design, and QA teams to identify standards, maintain QMS targets, and document validation activities. The role requires a bachelor’s degree and at least 8 years in quality, with strong leadership and communication skills.

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 8 years in quality or related field experience.
• Experience in standard review and product testing preferred.

Responsibilities

• Lead creation of documentation to maintain product and quality system compliance.
• Manage compliance targets and lead gap assessments for changes.
• Coordinate with engineering to determine applicable standards and validation needs.
• Review and revise product documentation to ensure regulatory targets.
• Lead process improvements to maintain QMS compliance.
• Support audits (MDSAP, ISO 13485, MDR, etc).
• Represent QMS QA in cross functional meetings.
• Mentor others on compliance practices.

Skills

Leadership

Organizational skills

Regulatory knowledge

Training others

Project management

MS Office proficiency

Communication

Education

Bachelor's degree in engineering or life sciences

Tools

Microsoft Office

Visio

Job description

New World Medical in Rancho Cucamonga, CA is seeking a Compliance/QA Manager responsible for ensuring product compliance to testing and regulatory standards, leading improvement projects, and supporting audits.

You will collaborate with engineering, design, and QA teams to identify standards, maintain QMS targets, and document validation activities. The role requires a bachelor’s degree and at least 8 years in quality, with strong leadership and communication skills.