Senior Microbiologist - Quality & Risk Leader (Med Devices)

Integrated Resources, Inc ( IRI ); Saint Paul (MN); On-site; USD 95,000 - 135,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks an experienced Senior Microbiologist to provide technical support for contract manufactured devices, microbiology risk assessments, and quality system activities across the organization.

As a microbiology SME, you will collaborate with Manufacturing, Quality, Regulatory Affairs, R&D, and external partners to evaluate risks, support investigations, and ensure compliance with FDA, ISO 13485, and other global requirements.

Qualifications

• Bachelor's degree in Microbiology or related field.
• Minimum of five years' experience in microbiology/quality within a regulated industry.
• Strong technical writing and documentation skills.
• Ability to independently manage multiple projects and priorities.
• Strong communication and stakeholder management skills.

Responsibilities

• Serve as a microbiology SME supporting contract manufactured devices and external manufacturing partners.
• Support acquisition due diligence activities, product integration efforts, and manufacturing transfer initiatives.
• Perform microbiological risk assessments for products, materials, manufacturing processes, facilities, and supplier changes.
• Author and review Microbiology Evaluation Reports (MBERs), technical assessments, and supporting scientific documentation.
• Evaluate microbiological impact associated with product, process, material, supplier, and facility changes.
• Support investigations, nonconformances, CAPAs, and other quality system activities requiring microbiology expertise.
• Partner with cross-functional teams to assess microbiological considerations related to manufacturing, design changes, commercialization activities, and supplier controls.
• Provide microbiology support for new product development projects and product lifecycle management activities.
• Participate in audits, inspections, and regulatory readiness activities as needed.
• Support continuous improvement initiatives and implementation of microbiology-related quality system enhancements.
• Communicate microbiological risks, recommendations, and technical rationale to stakeholders across multiple functions and geographic regions.

Skills

Technical writing

Risk assessment

Project management

Microbiology expertise

Stakeholder communication

Education

Bachelor's degree in Microbiology

Job description

Integrated Resources, Inc (IRI) seeks an experienced Senior Microbiologist to provide technical support for contract manufactured devices, microbiology risk assessments, and quality system activities across the organization.

As a microbiology SME, you will collaborate with Manufacturing, Quality, Regulatory Affairs, R&D, and external partners to evaluate risks, support investigations, and ensure compliance with FDA, ISO 13485, and other global requirements.