Microbiology Quality Analyst, Bioburden & Sterility

Applied Medical Corporation; Rancho Santa Margarita (CA); On-site; USD 73,000 - 75,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

Training programs

Wellness activities

Education reimbursement

401(k) matching

Generous vacation

Paid holidays

Job summary

Applied Medical Corporation is seeking a microbiology analyst to support bioburden and sterility testing for medical device manufacturing. You will maintain laboratory records, review data, and ensure regulatory and quality system compliance, under supervision.

This role emphasizes analytical support and cross-functional collaboration. The position involves coordinating external lab testing, audits, and document preparation, with opportunities to contribute to process improvements and quality

Qualifications

• BS in Biological Sciences or related technical field required.
• Two to three years of relevant experience in medical device or regulated environment preferred.
• Familiarity with laboratory records, compliance, and regulatory expectations.

Responsibilities

• Coordinate bio testing activities including bioburden and sterility with external labs.
• Coordinate audits and ensure timely compliance with procedures and standards.
• Prepare and maintain testing protocols, study plans, and final lab reports.
• Maintain data, identify trends, and support investigations and improvements.
• Collaborate with Engineering, Manufacturing, Quality, and cross-functional teams.

Skills

Microbiology techniques

Data analysis

Analytical thinking

Communication skills

Problem solving

Education

BS in Biological Sciences

Job description

Applied Medical Corporation is seeking a microbiology analyst to support bioburden and sterility testing for medical device manufacturing. You will maintain laboratory records, review data, and ensure regulatory and quality system compliance, under supervision.

This role emphasizes analytical support and cross-functional collaboration. The position involves coordinating external lab testing, audits, and document preparation, with opportunities to contribute to process improvements and quality