Senior Manager, Sterility Assurance

Stryker Group; Carrigtwohill; Hybrid; EUR 92,000 - 154,000; Full time

Job summary

Stryker Group seeks a permanent hybrid Sterility and Microbiology leader to drive enterprise-wide compliance with global sterilization standards across product development, manufacturing, and distribution. You will advocate for sterilization and microbiology excellence, influencing senior leadership and cross-functional teams to prioritize quality and patient safety.

You will provide technical oversight of sterilization methods, lead investigations, and partner with R&D and manufacturing to

Qualifications

• Bachelor’s degree is required.
• Minimum of 10 years in a manufacturing environment with responsibility for cleaning and sterilization processes and/or microbiology lab oversight.
• Minimum of 4 years of team leadership and people management experience.

Responsibilities

• Develop, implement and maintain enterprise-wide sterilization and microbiology assurance policies aligned with global regulatory standards (FDA, ISO, EU MDR).
• Standardize sterilization procedures across all sites for consistency and compliance.
• Lead investigations and CAPAs for sterilization or microbiology nonconformances and drive corrective actions.
• Provide technical oversight for sterilization methods (EO, gamma, steam, e-beam) and microbiological testing.
• Drive enterprise training and awareness programs on sterilization and microbiology.

Skills

Leadership

Regulatory compliance

Quality systems

Education

Bachelor’s degree

Science/Microbiology degree

ISO Lead Auditor training

Certified Quality Engineer (ASQ)

Job description

This is a permanent Hybrid role that can be based out of Ireland, Germany or France.

This Sterility and Microbiology role will serve as a strategic leader responsible for driving enterprise-wide compliance with global sterility and microbiological standards across all activities.

This role ensures that all operations, from product development through manufacturing and distribution, adhere to regulatory requirements and harmonized best practices, safeguarding patient safety and product integrity.

What you will do:

Sterilization policies, procedures, and processes

• Create policy and procedures to enable standardized approach to sterilization alignment across Stryker, inclusive of sterilization validation and sterilization product transfers
• Drive QMS / RA alignment to support sterilization transformation in an agile manner utilizing our product transfer process
• Develop, implement, and maintain enterprise-wide sterilization and microbiology assurance policies aligned with global regulatory standards (FDA, ISO, EU MDR, etc.).
• Standardize sterilization procedures across all manufacturing sites to ensure harmonization and consistency.
• Establish and monitor sterilization validation and requalification programs, ensuring robust risk management and compliance.
• Responsible for building appropriate process and procedures as we ramp and build new infrastructure in the sterilization supply chain
• Leverages successful working relationships with internal and external personnel in various departments to advance business goals.

Sterilization advocacy

• Serve as the company-wide advocate for sterilization and microbiology assurance, promoting a culture of compliance and scientific rigor.
• Influence senior leadership and cross-functional teams to prioritize sterilization assurance in product development and lifecycle management.
• Represent the company in external forums, regulatory inspections, and industry working groups to shape and align with evolving standards.
• Drive enterprise training and awareness programs to build organizational expertise in sterilization and microbiology.

Technical Responsibilities:

• Provide technical oversight for sterilization methods (e.g., ethylene oxide, gamma irradiation, steam, e-beam) and microbiological testing.
• Evaluate and approve sterilization process changes, ensuring compliance with regulatory and quality requirements.
• Lead investigations and root cause analyses for enterprise wide/trending sterilization or microbiological nonconformances, implementing corrective and preventive actions to corporate procedures and guidance documents to enable compliance.
• Monitor emerging technologies, standards, and scientific advancements to proactively adapt company practices.
• Partner with R&D and manufacturing teams to integrate sterilization assurance into product design, development, and scale-up.

Compliance & Harmonization:

• Ensure enterprise-wide alignment with global sterilization and microbiology standards, reducing variability across sites.
• Maintain audit readiness and provide expert guidance during regulatory inspections.
• Establish metrics and reporting systems to track sterilization compliance performance across the organization.
• Drive continuous improvement initiatives to strengthen quality systems and enhance patient safety.

What you need required:

• Bachelor’s degree
• Minimum of 10 years of experience in a manufacturing environment, with direct responsibility for cleaning and sterilization processes and/or oversight of microbiology laboratory operations within the medical device or pharmaceutical industry.
• Minimum of 4 years of experience in team leadership and people management, with a proven ability to guide, develop, and motivate high-performing teams.

Preferred

• Bachelor’s degree or higher in science, Microbiology or biological science preferred.
• ISO Lead Auditor training
• Certified Quality Engineer (ASQ)

Ireland Pay Ranges:

• Ireland: €92,000 - €154,000 EUR Annual

At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.