The Microbiology Supervisor will work primarily with Volcano products and processes that require environmental controls used in the development or manufacture of Intravascular Ultrasound and Functional Measurement medical devices.
This position will provide cleanroom management expertise relative to the environmental control of clean rooms managed by Volcano, assuring they meet established applicable regulatory requirements.
This position will establish and maintain processes, document validation protocols, investigate and drive appropriate corrective / preventive actions relative to non-
conformance issues, on-going trending of environmental and sterilization data.
Provides expertise to microbiological methods and processes related to Volcano products designed and manufactured, as well as products purchased.
Assure appropriate action is taken relative to the release or quarantine of sterilized product.
Ensures the Microbiology functions operate according to procedures and provides direction to staff. Manages personnel, including coaching, mentoring, evaluating performance, and disciplinary actions.
Establish robust environmental monitoring process controls.
Write, reviews and approves quality document changes (ECO, MCO and Deviation)
Provide routine reports including trends of sterilization or environmental monitoring results.
Requires a Bachelor’s degree in Microbiology or related field.
KNOWLEDGE AND EXPERIENCE :
Requires 3+ years experience in a microbiology function within the bio-medical, medical device, or pharmaceutical industry.
Knowledgeable in the following Microbiology tests : LAL, Bioburden, Biologic Indicator (BI), Water sampling, pH testing, Environmental Monitoring
Demonstrated experience, proficiency and strong technical expertise regarding microbial identification, sterility assurance, contamination control and clean room testing procedures, technique and methods.
Knowledgeable of FDA regulations, Quality System Regulations (QSR), ISO 13485, Good Laboratory Practices (GLP) and Japan regulations.
Knowledgeable of ANSI / AAMI / ISO 11135-1 : 2007 Sterilization of health care products
Ethylene oxide Part 1 : Requirements for development, validation, and routine control of a sterilization process for medical device and Part 2 : Guidance on the application of ISO 11135-1
Knowledgeable of ISO 14644-1 through 14644-9 : Clean rooms and associated controlled environments
LICENSES AND CERTIFICATIONS : None
ADDITIONAL DESIRABLE QUALIFICATIONS :
Green or Black Belt, preferred
Certified Quality Auditor, preferred
SKILLS AND ABILITIES :
Ability to work effectively in a highly matrixed organization.
Exceptional listener and communicator who effectively conveys information verbally and in writing
Highly analytical thinker with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.
Flexible team player who thrives in environments requiring ability to effectively prioritize and juggle multiple concurrent projects.
Results-driven achiever with exemplary planning and organizational skills, along with a high degree of detail orientation.
Innovative problem-solver who can generate workable solutions and assure implementation of those solutions.
PROBLEM SOLVING AND DECISION MAKING :
Practical application of 7-step or 9-step problem or equivalent structured problem solving techniques
Makes data drive decisions in a timely manner.
PHYSICAL REQUIREMENTS :
Ability to hear and speak to employees and outside business associates on the phone and in person
Ability to view details in a microscope, see the letters and numbers on a personal computer screen, memos, reports, and other documents as well as projected slides on a screen
Ability to work in an office environment, including in front of a computer, at a work desk, and on the phone, interacting with people, as well as in manufacturing and inspection areas, including clean rooms requiring dressing in clean room attire
Requires moderate right and left hand coordination for the use of the personal computer
Requires the ability to communicate both oral and in writing via computer.
Hand-eye coordination and capable to walk considerable distances.
SUPERVISORY RESPONSIBILITY :
Manages exempt and nonexempt staff; makes hire, performance evaluation, termination, promotion and merit decisions
TRAVEL REQUIREMENTS :
May be required to travel both domestically and internationally to Volcano offices, customer and vendor locations