Quality Assurance Engineering Specialist I

TL;DR

Quality Assurance Engineering Specialist I (Medtech): Support quality engineering activities to ensure compliance with domestic and international regulations, including assembling sterile loads, verifying sterilization processes, and analyzing data for statistical process control. Focus on documenting device history records, maintaining quality files, and interfacing with departments, suppliers, and sterilization facilities.

Location: Onsite in Alameda, CA. Willingness to work on site required. May have business travel 0-5%.

Starting Base Salary: $30.00 to $40.00 per hour

Company

Global healthcare company focused on innovative therapies for challenging medical conditions, headquartered in Alameda, California.

What you will do

• Assemble sterile loads and complete associated documents for sterilization and product release.
• Verify and document accuracy of sterilization processes, biological test results, and Device History Records (DHRs).
• Perform data entry, review, and analysis to support statistical process control.
• Maintain and control quality record files and archived records.
• Communicate with sterilization facilities, test laboratories, internal departments, customers, and suppliers on quality issues.
• Adhere to the Company’s Quality Management System (QMS) and relevant regulations.

Requirements

• Bachelor’s degree in a scientific or engineering discipline with 1+ years of quality systems experience in regulated device or pharmaceutical environment (or equivalent).
• Excellent oral, written, and interpersonal communication skills.
• Problem solving and documentation skills.
• Ability to work onsite in general office, production, and cleanroom environments in Alameda, CA.
• Potential exposure to blood-borne pathogens; lifting up to 25 pounds.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Generous benefits package including medical, dental, vision, life, AD&D, short/long-term disability insurance.
• 401(k) with employer match, paid parental leave, eleven paid company holidays, minimum fifteen days accrued vacation (increases with tenure), paid sick time.