Location: Columbia Heights, Minnesota
Posted On: 9/12/2017
Job Code: MBS_MN_2132
Job Description
Job Title: Microbiologist-Steriliz
Location: Columbia Heights MN 55421
Duration: 06 months (High possibilities of extension)

Position Description:

This Manufacturing Quality role will provide daily technical leadership for Sterilization Services, including CEA (clean room), Microbiology Laboratory Operations, and Parts Cleaning.

By partnering with the Neuromodulation Microbiology team, this quality engineer will:

Assist in creating and maintaining department Work Instructions, processes, and requirements.
Assure that products and processes are in control and in compliance with corporate, division and regulatory agency requirements by the detection, appraisal, correction and prevention of sterilization, contamination and environmental control concerns.
Make independent technical and functional decisions regarding acceptance or rejection of product components, subassemblies, solutions and the suitability of processes.

Assure that all activities are in compliance with FDA GMP/GLP, ISO 13485, EN46001, MDD and other applicable standards and requirements.

Position Responsibilities:

This is largely a tactical role where the individual will serve as the voice of quality to the micro-biology, sterilization and parts cleaning teams to ensure stable production and rapid resolution of issues when they arise.

• Assure all Quality requirements are in compliance with regulations and product specifications
• Provide technical leadership and support to Operations and Sterilization Services personnel, including review and disposition of product non-conformances and out-of-tolerance conditions.
• Partner with Microbiology team to update Sterilization Services technical procedures, MFG processes/work instructions, validation protocols/reports, and CEA compliance documents
• Apply knowledge to the optimization of the sterilization process for multiple product lines and projects
• Provide production support for the clean room, sterilization and parts cleaning areas
• Provide new product development sterilization / microbiology validation support
• Review and approve all areas of sterilization validation (EtO, radiation, and steam)
• Work with little guidance to help design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Work with little guidance to help develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within company.
• Lead the analysis of issue trends and escalation process as necessary to maintain compliance to internal CAPA procedures.
• Use Continuous Improvement methodologies to improve quality and first time yield while reducing non-value added activities and cost
• Support internal and external audits, and assist with written responses to FDA for IDE’s, PMA’s and PMA supplements.
• Review engineering change orders.
• Be a team member to resolve non conformances and implement corrective action
• Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement/corrective activities.
• Participate or lead special projects as assigned.

Basic Qualifications:

• Bachelors Degree
• 5+ years experience as a Microbiologist with medical device operations experience.

• Expertise in the following areas:
• Sterilization standards, compliance documents, endotoxin testing (including standards compliance), microbiology lab testing (including bioburden and sterility testing), EtO residual testing and requirements, CEA compliance and certification.
• Parts Cleaning experience
• Project Management.
• Good written and verbal communication skills.
Category:IT  code:new
Job Requirements
Engineering, ISO 9001, Compliance, Management, MS Access, Project Management, IQ/OQ/PQ, CAPA

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Contact Details
Shubhro Biswas