Sterilization & Environmental Quality Manager - Hybrid - 20709

$93,000 - $144,000/Yr

Mattson Resources - Santa Clarita, CA

Full-time - Mid Level

Hybrid - Santa Clarita, CA

Administrative and Support Services

About the position

The Sterilization & Environmental Quality Manager is responsible for overseeing all quality assurance activities related to product sterility and environmental cleanliness in a growing billion-dollar electromechanical Class III implant medical device company. This role involves leading efforts to ensure effective sterilization processes for implantable devices, maintaining a controlled manufacturing environment, and ensuring compliance with industry regulations.

Responsibilities

• Develop and manage strategies for sterilization and environmental monitoring.
• Oversee testing, validation, and deployment of sterilization equipment.
• Ensure adherence to regulatory standards and internal procedures.
• Monitor cleanliness levels (bioburden, bacterial endotoxins) to ensure product safety.
• Lead audits, manage non-conformances, and drive continuous process improvement.
• Train and mentor team members, manage project timelines, and support external audits.

Requirements

• Bachelor's degree in Microbiology or a related field.
• 5+ years of management experience in sterilization and environmental monitoring within the medical device industry.
• Strong knowledge of sterilization standards (ISO, CFR) and quality system regulations.
• Excellent leadership, communication, and project management skills.