Quality Engineer II - Planet Pharma

Quality Engineer II

Location

Irvine, CA

Contract Duration

6 months

Target Pay Rate

$42/hr. with flexibility

About the Team

Our group focuses on New Product Development (NPD) quality and design assurance for medical devices, particularly in the area of transcatheter heart valve replacement (TAVR). This is a transformative area of healthcare, offering life-saving solutions without the need for open-heart surgery. We are looking for a dedicated Quality Engineer to join our efforts in improving patient care.

Key Responsibilities

• Support Quality AssuranceDesign ControlsRisk ManagementManufacturing Controls, and Statistical Techniques in NPD programs.
• Investigate complex product quality issues and compliance problems, analyze findings, determine root causes, and initiate corrective actions.
• Coordinate and execute change control processes to support rapid innovation.
• Assist with design and development activities, including feasibility testing, drawing reviews, and engineering studies.
• Participate in Project Risk Assessments (PRA) and escalate critical tasks as needed.
• Develop and validate test methods for Design Verification testing and manufacturing inspections
• Collaborate with R&D and Manufacturing teams to facilitate the execution of NPD processes and the launch of robust products.
• Develop and execute experiments to improve and validate product designs and manufacturing processes, analyzing results and preparing reports.
• Maintain and update risk management files and develop supporting documentation and training materials (e.g., work instructions).
• Oversee and assign tasks to technicians, provide guidance, and ensure successful completion of testing activities.
• Coordinate Management Review meetings, including preparing presentations and facilitating communication.
• Manage complaint coordination, including logistics, tracking, follow-ups, and communication, and ensure proper implementation of CAPA/NCR
• Perform other duties as assigned by leadership.

Required Qualifications

• Bachelor's degree in Engineering or a related scientific field, with a minimum of 2 years of experience in NPD, Quality Engineering, R&D, or Manufacturing, OR a Master's degree with relevant internship or project experience.
• Experience working in a highly regulated industry (medical device, healthcare, etc.).
• Proficiency in MS Office Suite, including MS Project
• Strong problem-solvingorganizationalanalytical, and critical thinking skills.

Preferred Qualifications

• Experience in medical devices, specifically in cardiovascular, endovascular, or other critical care/surgical products.
• Design Assurance expertise, including Design ControlsDesign Verification & ValidationTest Method Development, and Process Validation
• Experience conducting root cause analysis and investigations related to complaints, NCRs, and CAPAs
• Experience with New Product Development from concept to commercialization (Class III products preferred).
• Basic understanding of statistical techniques and risk management

Additional Information

• Minimal travel required, up to 10%, for domestic and international needs.
• Location: Irvine, CA, ideally in the T&D building.
• Flexible work schedule with potential overtime if needed for urgent issues.