Title:  Quality Project Manager - Sterilization

Job Summary

The Quality Project Manager – Sterilization is responsible for leading and executing sterilization-related quality initiatives across manufacturing sites. This role combines strong sterilization technical expertise (EtO, steam, gamma) with structured project management capabilities to drive standardization, compliance, continuous improvement, and quality maturity. The position supports the development and implementation of standardized sterilization processes, validation programs, and QMS improvements while ensuring compliance with FDA, ISO 13485, and applicable regulatory standards. This role works cross-functionally with Engineering, Operations, Regulatory, R&D, and Quality teams to execute projects on time, within scope, and within budget.

Essential Duties and Responsibilities

• Support the development, harmonization, and deployment of standardized sterilization procedures and quality practices across multiple sites.
• Coordinate sterilization validation activities, including initial process validations, revalidations, and annual re-qualifications to maintain a validated state.
• Author, review, and approve sterilization protocols, validation reports, technical documentation, and related procedures in accordance with internal standards and regulatory requirements.
• Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, applicable cGMP requirements, and other global regulatory standards.
• Support environmental monitoring programs and implement risk-based validation and control strategies.
• Monitor, track, and trend sterilization process data to identify improvement opportunities, ensure process capability, and maintain compliance.
• Participate in regulatory inspections and audits and provide front-room and back-room support for sterilization-related activities.
• Lead cross-functional sterilization and quality improvement projects from initiation through closure, ensuring alignment with business objectives.
• Develop project charters, timelines, resource plans, and budgets, and identify, assess, and mitigate project risks throughout the project lifecycle.
• Manage project scope, schedule, and cost controls using structured project management methodologies.
• Assemble and coordinate cross-functional project teams, define clear deliverables, and ensure accountability.
• Measure and report project performance using defined KPIs and quality metrics and communicate progress, risks, and outcomes to key stakeholders.
• Support standardization and continuous improvement of quality systems and sterilization practices across sites.
• Lead or contribute to CAPA, root cause analysis, FMEA, and broader risk management activities to address quality and compliance gaps.
• Develop, analyze, and report quality performance metrics related to sterilization effectiveness and cost of quality.
• Drive Lean and Six Sigma initiatives to improve sterilization cycle efficiency, strengthen compliance robustness, and optimize cost performance.
• Coordinate corrective and preventive actions resulting from customer complaints, audit findings, or operational nonconformances.
• Collaborate closely with Engineering, R&D, Operations, and Regulatory teams to support product and process transfers, validations, and continuous improvements.
• Support evaluation and implementation of new sterilization technologies, industry best practices, and process enhancements.
• Ensure proper change control processes are followed, including completion of risk assessments, impact analyses, and FMEA documentation.

Additional Responsibilities

• Works independently with minimal guidance.
• Develops technical knowledge, requires working knowledge and experience in project management.
• Manages single workstreams locally/globally and may work across multiple workstreams.
• Maintain clear communication paths with stakeholders.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

Education

• Bachelor's Degree Science related field, Chemistry, Biology, engineering required

Work Experience

• Preferred previous ETO, steam/gamma sterilization experience
• 3+ years experience in a similar position within the manufacturing industry
• Good knowledge of LEAN and 6 sigma manufacturing principles
• Very good organizational and project management skills
• Excellent communication skills and ability to successfully collaborate with teams across different countries and organizational levels
• Highly analytical and structured way of working
• Self-motivated, results- and solution-oriented personality

Preferred Knowledge, Skills and Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation
• Maintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications
• Experience working with ISO13485, FDA and cGMP preferred
• Understanding and experience in use of Lean manufacturing principles preferred
• Ability to write routine reports, correspondence, and process documents
• Excellent organizational and communication skills.
• Works independently with minimal guidance
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times #LI-AP1 #LI-HYBRID

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification preferred

Travel Requirements

Physical Requirements