Senior Equipment Engineering Technician (Regulatory & QA)

Caris MPI, Inc.; Phoenix (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Caris Life Sciences in Phoenix, AZ seeks a Senior Equipment Engineering Technician to install, maintain, and repair laboratory equipment, ensuring safety and performance. You will support the Equipment Engineering Supervisor, assist with project management, and help develop maintenance strategies.

Responsibilities include auditing processes, writing SOPs for the QMS, analyzing quality data, CAPA coordination, and training technicians.

Qualifications

• Bachelor’s degree in biological science, engineering, or similar field.
• A minimum of 3 years of experience working within an FDA-regulated laboratory, medical device, or pharma environment.
• Familiar with ISO13485, ISO9001, CAP/CLIA, and FDA regulations/requirements
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook

Responsibilities

• Participate in internal and external audits.
• Manage company records in accordance with regulatory requirements and company policies.
• Author, review, revise, and implement standard operating procedures (SOP’s) for the QMS.
• Analyze and implement improvements in equipment management processes to increase scalability and consistency of performance.
• Develop associated programs and create job aides.
• Capture, trend, analyze quality data, and identify areas for improvement.
• Be involved in the resolution of Nonconformances (NONC) and Corrective Action Preventive Action (CAPA) events.
• Collaborate with the cross-functional teams to achieve defined business objectives.
• Use creative problem-solving skills to identify, solve, or improve processes.
• Review records for accuracy.
• Utilize the Master Site Validation Plan to minimize logistical challenges in completing equipment tasks.
• Coordinate with approved vendors to perform equipment calibrations, preventative maintenance, and repairs.
• Perform equipment repairs, calibrations, and/or maintenance as required.
• Prepare, coordinate, and lead training of Equipment Engineering Technicians and/or members of other departments.
• Other duties as assigned.

Skills

Regulatory compliance

Audits

SOP development

Quality data analysis

Training

Problem solving

Education

Bachelor's degree in biological science or engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Caris Life Sciences in Phoenix, AZ seeks a Senior Equipment Engineering Technician to install, maintain, and repair laboratory equipment, ensuring safety and performance. You will support the Equipment Engineering Supervisor, assist with project management, and help develop maintenance strategies.

Responsibilities include auditing processes, writing SOPs for the QMS, analyzing quality data, CAPA coordination, and training technicians.