Description
Company: Medtronic Title: Microbiologist- Sterilization Type: 12 month contract Location: Will consider remote candidates anywhere in the US but will give preference to local candidates to Minneapolis, MN. We are seeking a Microbiologist-Sterilization for a very important client. Responsibilities may include the following and other duties may be assigned: Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices Complete studies needed to address compliance requirements for medical device microbial control and sterility Create and/or update technical documentation, programs, and processes as needed to align with EU MDR and international regulation and standard guidance Collaborate with internal and external crossfunctional teams to ensure successful implementation of program/process changes needed to meet regulations Train and adhere to quality system procedures applicable to products in scope of responsibilities The ideal candidate will possess the following qualifications: Top skills needed: 1. Practical experience applying the listed external standards, especially ISO 11135, ISO 11737, and AAMI ST72 2. Ability to work independently to meet milestones on a long term projects 3. Ability to effectively communicate progress and challenges to project team to ensure deadlines are met Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience (Medical Device and/or Microbiological Laboratory), or advanced degree with 0 years of experience. Preferred Qualifications: Familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices. Understanding of different types of sterilization methods (EtO, radiation, steam, etc.) including processes and equipment Knowledge in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO), ISO 11737 (Microbial Method, ISO 10993 (Biocompatibility), ISO 14644 (Controlled Environments), ANSI/AAMI ST72 and others as applicable (i.e. EN). Proven collaborator and team player. Excellent organizational and judgment. Ability to maintain and generate accurate records. Strong written and verbal communication skills
