Medical device Quality specialist

Position: Medical Device Quality Specialist

Location: Temecula, CA; Irvine, CA; Santa Rosa, CA; Plymouth, MN; St. Paul, MN; Buffalo Grove, IL; Maine

Duration: 12 Months on W2

Note: Relocation must be acceptable OR must have some preferred locations for ON-SITE

Job Summary

We are seeking Medical Device Quality Specialists at entry and junior levels for a 12-month contract. The successful candidates will support quality engineering activities within the Reliability Engineering Lab, focusing on equipment qualification, calibration, maintenance, and repairs, as well as ensuring regulatory compliance in medical device manufacturing. This role involves managing lab-related projects, addressing nonconformance issues, and deploying new software and recipes into testing equipment.

Key Responsibilities

• Oversee equipment qualification, coordinate calibration and maintenance, and collaborate with various teams for necessary repairs.
• Qualify and implement new software and recipes for testing equipment.
• Manage multiple projects related to lab operations and nonconformance issues.
• Ensure compliance with LifeScan software development procedures and industry regulations by consulting with Manufacturing, Information Management, R&D, Quality Assurance Operations, and Product Performance Analysis teams.
• Review and approve deliverables throughout the software development lifecycle.
• Lead hazard analysis teams.
• Assist in the development of Standard Operating Procedures and Work Instructions tailored to specific software development needs.
• Provide training on software development activities.
• Write and execute test protocols and reports as needed.
  
  

Required Qualifications

• Entry-Level
• Bachelor's degree in Pharma, Biotechnology, or a related field.
• Strong desire to learn and develop skills in quality and regulatory engineering.
• Excellent communication and teamwork skills.
• Junior Level
• Bachelor's degree in Pharma, Biotechnology, or a related field.
• 1 to 5 years of experience in quality engineering.
• Experience in equipment qualification and regulatory compliance.
• Strong project management skills.
  

If you are looking for a position in the Medical Device, Pharmaceutical, or Industrial sectors, please contact me at [email protected] ASAP.