Job Description:

This position is a key role in the Quality organization. Primary areas of responsibility will be on-site and off-site sterilization and managing subordinates in these areas. This role is responsible for carrying out duties in accordance with the organization's policies and applicable laws.

Responsibilities will include implementation of the quality systems, processes and procedures in the sterilization departments.

This role is responsible for training employees; planning, assigning, directing and executing work; and resolving problems.

Additional focus will be on implementing continuous improvement, supporting equipment/system upgrades and new equipment/systems.

Cross-functional teamwork will be involved in this role as well.

Responsibilities:

• Responsible for the scheduling of sterilization services in house and with Contract Sterilizers.
• Responsible for sterilization qualification and requalification scheduling and execution of studies.
• Responsible for scheduling and execution of temperature mapping studies across the facility.
• Must perform process validation, process capability, and process control studies for assigned areas.
• Must drive quality/manufacturing projects utilizing Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technology.
• Analyze and assess current systems to assure regulatory compliance.
• Facilitate the validation status of key process equipment.
• Plan and prioritize multiple projects to ensure completion within the target dates.
• Perform failure investigations and track follow-up corrective actions as indicated.
• Must assist in the identification and development of process improvement projects including automation and computerization.
• Responsible for ensuring FDA regulations are met for system upgrades/replacements.
• Ability to function effectively as a member of a team.
• Ability to communicate effectively in written and verbal form.
• Responsible for Specification/SOP compliance for sterilization processes (EO, gamma, steam)
• Evaluate and assist in ways to improve supplier and plant processing characteristics to improve the quality and cost of sterilized products.
• Support and assist in activities to assure products’ sterility is maintained.
• Responsible for Quality management activities in supporting the plant unreleased and released sterilized products.
• Must perform other duties and responsibilities as determined by supervision/management.
• Must have knowledge of both plant and departmental environmental health and safety regulations and comply with said regulations accordingly.