Regional Manager of Sterility Assurance


About this job

  • Industry: Medical devices
  • Area of expertise: Regulatory
  • Location: Maple Grove

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor

About this role: Regional Manager of Sterility Assurance

Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. Their portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.

The incumbent in this role is responsible for managing the resources required to assure compliance and quality related to sterility assurance and re-usable cleaning/sterilization processes.

  • Provide tactical leadership and direction by managing the Sterility Assurance Department team consisting of varying levels of professionals to provide shared services to all business units.
  • Lead and provide expertise as the sterilization subject matter expert (SME) for Company and its various divisions.
  • Responsible for maintaining the sterility assurance database for company and assuring compliance to relevant domestic and international standards (if applicable).
  • Represent company and interface with FDA and third-party auditors/investigators during audits as the SME for sterilization, microbiological and environmental controls for manufacturing facilities.
  • Manage department resources to work with teams to launch new products and assess design changes for existing products.
  • Manage department resources to provide sterilization, microbiological and environmental control expertise during supplier quality audits of critical suppliers/vendors.
  • Manage department resources to provide microbiological expertise for environmental controls of existing and newly built class cleanrooms and other controlled manufacturing environments.
  • Manage resources to assure compliance with ISO standards for the various product lines and sterilization processes.
  • Assure annual requalification activities and quarterly dose audits are performed in a timely manner so that no supply chain interruptions occur.
  • Create process maps and perform gap analyses for sterilization and microbial processes as needed.
  • Manage resources necessary to have compliant and validated cleaning and sterilization processes for re-usable instrumentation (if applicable).
  • Develop and maintain reusable cleaning/sterilization database for company products to be used and reference in products evaluation (if applicable).
  • Manage resources responsible for re-usable cleaning/sterilization evaluations and/or validations for company Medical projects, including, new products and existing product improvement, and new markets (if applicable).
  • Develop protocols, technical reports and directs validation, as necessary for re-usable cleaning/sterilization (if applicable).
  • Maintain re-usable cleaning/sterilization related procedures current per relevant domestic and international standards (if applicable).
  • Maintain contact and able to negotiate with laboratory and consultant suppliers.
  • Assure that product/process control methods for use are validated prior to publication.
  • Provide leadership and expertise to close CAPA's and non-conformances; reduce sterilization non­ conformances via creation of a quality culture.
  • Support the maintenance of harmonized procedures used globally.
  • Provide support to in-house microbiology and chemistry labs to provide efficient and compliant work processes, as these labs provide support to several manufacturing locations.
  • Develop and lead strategic initiatives to improve cycle time and sterilization processes/efficiencies, such as conversion to parametric release, consolidation of sterilization families and cycles, creating overlap and redundancy between existing cycles and new cycles during cycle development.
  • Lead all aspects of talent management (i.e. recruiting, performance management, development)


  • B.S. degree in Science (Microbiology, Biology, Medical Technology, etc.) required. M.S. or M.B.A. preferred.
  • SQ CQA or COE or 6 Sigma certified preferred
  • Minimum 7-10 years experience in sterilization and laboratory operations.
  • Experience in EO and gamma radiation sterilization and re-usable sterilization is preferred.
  • Minimum of 5 years of management of exempt employees which included technical oversight required. Experience supervising laboratory staff preferred.
  • Regulatory, cGMP, QSR, knowledge base.
  • Statistical Knowledge (DOE, SPC, Hypothesis testing, Sample Comparison).
  • Computer literate (i.e., data-base development, statistical software and analysis, word processing for report generation, etc.)
  • Negotiation and problem-solving skills.
  • Ability to operate and communicate effectively with multiple teams.
  • Supplier auditing skills, (i.e., ASQ-CQA, internal/ external courses, seminars).
  • Knowledge and experience in Sterilization (especially EO and gamma radiation).
  • Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts


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Any questions remaining?

Your consultant, Max Schumacher is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Max Schumacher
Brunel USA - Minneapolis

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