Quality Project Manager - Sterilization

About the role

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.

Responsibilities

• Support the development, harmonization, and deployment of standardized sterilization procedures and quality practices across multiple sites.
• Carefully 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.
• Maintain and monitor 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.

Requirements

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

Qualifications

• Preferred previous ETO, steam/gamma sterilization experience
• 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
• 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