Sr QA Specialist-Sterilization

Sr QA Specialist-Sterilization

Requirements

• Bachelor’s degree required, Master’s degree preferred.
• 08-10 years related experience required.
• Occasional business travel required.
• Regular and predictable attendance

Responsibilities

• Provides Quality support to sterilization activities through education, partnering and monitoring for quality compliance while assuring that products and process continue to operate in accordance with company policies and procedures.
• Responsible for managing activities related to validating and revalidating sterilization equipment, methods and products in accordance with industry standards and regulations and company policies and procedures. This includes the development of master plans, maintaining project schedules and development, review and approval of validation protocols and reports to support pre-humidification, sterilization and aeration cycles.
• Operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.
• Responsible for overseeing Facilities, utilities and Maintenances for maintaining high quality levels., coordinating and administering the company quality program, and ensuring compliance with ISO, internal policies, SOPs, and any relevant external regulations.
• Operates in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.

Preferred Qualifications

• While performing the duties of this job, the employee is regularly required to sit and talk or hear.
• The employee frequently is required to use hands to handle or feel and reach with hands and arms.
• The employee is occasionally required to stand and walk.
• The employee must occasionally lift and/or move up to 20 pounds.