Cleanliness and Contamination Control Manager
Nobel Biocare - Yorba Linda, CA
Hiring: Cleanliness and Contamination Control Manager Company: Nobel Biocare Location: Yorba Linda, CA Job Posted Time: 2026-09-03 10:18:47 Employment Type: Contract About the job Experience: •ERP experience; SAP is a plus Required Skills: •Define and maintain contamination control and cleanliness control strategies. •Drive improvements to enhance cleanliness control, including cleanroom setup, product final cleaning, tool cleaning, hygiene, and rules of conduct. •Create/update procedures for cleanliness and contamination control and ensure they are adhered to. •Ensure compliance with Quality Regulations, ISO, AAMI standards, and regional requirements. •Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination and cleanliness control procedures. •Ensure monitoring related contamination and cleanliness control is performed. •Analyze and interpret contamination control and cleanliness monitoring data, identifying trends and implementing corrective actions. •Act as a Cleanliness and Contamination Control Subject Matter Expert (SME) during routine operations and audits. Qualifications: •Bachelor’s degree in a relevant scientific discipline; Microbiology or Biology is a plus •2+ years of experience in the field of contamination control; medical device or pharmaceutical experience is required •Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision. •ISO 13485 experience (QMS for pharma or medical device) •ISO 11137 - 1&2 sterilization experience (Gamma irradiation) •ISO 14644, ISO 14698, ISO 8573 series experience required (Clean room & utilities) •ISO 10993-1 required (standard for evaluating the biological safety of medical devices within a risk management process) •Solid expertise in statistical data analysis •Comprehensive experience of manufacturing process needs to meet cleanliness requirements is a plus •Good interpersonal skills with ability to work effectively with other groups Compensation: •$105,200 - $128,600 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!