Senior Quality Engineer

United Pharma; California; Hybrid; USD 110,000 - 170,000; Full time

Job summary

United Pharma in Los Angeles County, CA seeks a Senior Quality Engineer to design, implement, and maintain quality systems supporting the development, manufacturing, and testing of medical devices. The role is hybrid, with collaboration across engineering, regulatory, and clinical teams to ensure compliance and robust product quality throughout the lifecycle.

You will lead risk assessments, root-cause analyses, and CAPA programs, review development deliverables, prepare quality documentation,

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field; advanced degree is a plus.
• Minimum five years in Medical Device Industry or similar regulated industry.
• Minimum seven years of experience in an engineering discipline (R&D, QA, OPS).
• Experience with medical device quality systems (ISO 13485, FDA 21 CFR 820) and risk management (ISO 14971).
• Strong analytical, problem-solving, and documentation skills, with cross-functional collaboration.
• Experience leading audits, managing CAPA programs, and using statistical tools for quality improvement is advantageous.

Responsibilities

• Design, implement, and maintain quality systems and processes.
• Define and execute quality plans, perform risk assessments, lead root cause analyses.
• Review development deliverables (requirements, DV, TM, RM) and drive CAPA actions.
• Collaborate with engineering, manufacturing, regulatory, and clinical teams to ensure compliance.
• Prepare quality documentation and support audits.
• Mentor team members on quality best practices.

Skills

Quality Engineering

Quality Management

QA/QC

Risk Management

Root Cause Analysis

Statistical Tools

Documentation

Cross-functional Teamwork

Analytical Thinking

Audits

Education

Bachelor’s Degree in Engineering

Advanced Degree preferred

Tools

CAPA Programs

FMEA

Statistical Software

Job description

The Senior Quality Engineer is a hybrid role based in Los Angeles County, CA. This position is responsible for designing, implementing, and maintaining quality systems and processes that support the development, manufacturing, and testing of Nervonik’s neuromodulation devices. Day-to-day activities include defining and executing quality plans, performing risk assessments, leading root cause analyses, review of development deliverables (requirements, DV, TM, RM etc) and driving corrective and preventive actions across cross-functional teams. The Senior Quality Engineer will collaborate closely with engineering, manufacturing, regulatory, and clinical teams to ensure compliance with applicable standards and regulations, and to maintain robust product quality throughout the product life cycle. The role also involves preparing quality documentation, supporting audits, and mentoring team members on quality best practices.

Qualifications

• Candidates should possess strong skills in Quality Engineering and Quality Management, including developing and optimizing quality systems and processes.
• Candidates should possess skills in Quality Assurance and Quality Control to ensure compliance with internal standards and external regulatory requirements.
• Candidates should possess expertise in Product Quality, including reliability, validation, and verification activities for complex medical devices.
• Experience with medical device quality systems (e.g., ISO 13485, FDA 21 CFR 820) and risk management (e.g., ISO 14971) is highly beneficial.
• Bachelor’s degree in engineering, science, or a related technical field; advanced degree is a plus.
• Demonstrated experience in a regulated medical device or biotechnology environment, preferably with implantable or neuromodulation products.
• Strong analytical, problem-solving, and documentation skills, with the ability to work collaboratively in cross-functional teams.
• Experience leading audits, managing CAPA programs, and using statistical tools for quality improvement is advantageous.
• Minimum five experience in Medical Device Industry or similar regulated industry.
• Minimum seven years of experience in an engineering discipline (RD, QA, OPS)
• Bachelor’s Degree in Engineering

Preferred Qualifications

• QCBD experience
• CQE or CQA
• Prior startup experience in Medical Device company