Sr. QA Specialist - Sterilization

Position Summary

The Senior QA Specialist – Sterilization provides quality and technical expertise for sterilization and related microbiology activities supporting manufacturing and laboratory operations. This role helps keep processes, equipment and products validated, compliant and inspection-ready while partnering across Quality, Manufacturing, Engineering, Laboratory teams and external vendors.

In this role, you will have the chance to:

• Provide Quality oversight and technical guidance for sterilization activities to maintain product and process compliance.

• Lead validation and revalidation of sterilization equipment, methods and products, including pre-humidification, sterilization and aeration cycles.

• Develop validation strategies and master plans, manage schedules, and author, review and approve protocols and reports.

• Resolve complex sterilization and microbiology issues using sound scientific and quality judgment.

• Ensure compliance with company procedures, FDA regulations, applicable ISO standards and Canadian Medical Device Regulations, where applicable.

• Partner with internal teams and external contractors/vendors, and provide technical guidance or training to less-experienced employees.

Essential Requirements

• Bachelor’s degree in microbiology, biology, engineering, life sciences or a related technical discipline.

• Minimum 8 years of related experience in Quality Assurance, sterilization, microbiology or validation within a regulated manufacturing environment.

• Experience with sterilization process validation/revalidation and validation protocols, reports and plans.

• Working knowledge of FDA regulations, applicable ISO standards and quality system requirements.

• Strong technical writing, problem-solving, communication and cross-functional collaboration skills.

• Ability to work independently, support external contractors/vendors and travel occasionally; regular and predictable attendance is required.

Preferred Experience Includes

• Master’s degree in a scientific, engineering or related technical discipline.

• Experience with sterilization cycles and QC Microbiology controls for sterile or sterilized products.

• Experience mentoring or providing technical direction to Quality or laboratory personnel.

Physical Demands & Work Environment

The following represents the typical physical demands and work environment of this position. Reasonable accommodations may be made for individuals with disabilities.

• Work is primarily performed in office and laboratory settings, with occasional exposure to production/manufacturing areas and generally low noise.

• The role requires frequent sitting; occasional standing, walking, reaching, pushing/pulling and talking; and lifting or moving up to 20 lbs. occasionally and 10 lbs. frequently.