RF Certification Coordinator & Documentation Specialist

Description

POSITION SUMMARY

• Coordinate Radio Frequency certifications and their renewal with UL Solutions for DENSICHEK products for various countries.
• Work with Regulatory and countries around the globe that have different processes to determine when an RF certificate is deemed valid. Radio Frequency (RF) certifications require coordination with UL-contracted parties to maintain compliance and certification status. Calendar maintenance for timely results.
• Create a photo-driven marketing supplement identifying DENSICHEK components with current labeling containing electrical symbols, global country RFID symbology, logos, etc.

• Responsible for development, support, and change control of assembly procedures and related documentation for instrument products, devices, and/or spare parts manufactured at bioMérieux, St. Louis.
• Creates, edits, and distributes various documentation in support of manufacturing processes

PRIMARY DUTIES

• Participate in / conduct bi-monthly meetings with UL regarding countries impacted by Radio Frequency and the tasks unique to each country. Maintain the online Repository once UL notifies bioMerieux of Certificate approval.
• Manage bi-monthly meetings with local marketing, regulatory, and project management for RF. This may include of sales volume impacted and the operating budget RF certifications per calendar year.
• Manage departmental Change Request workflows in TrackWise Digital in order to support Instrument Engineering projects and/or changes. Communicate with internal review teams to obtain approvals necessary for product/procedure release as defined by Company procedures and the FDA Quality Systems Regulations.
• Research, write, modify, and format assembly documentation consisting of hardware assembly and test methods according to departmental styles and standards. Proofread documentation for accuracy and adherence to standards
• Consolidate and reconcile all comments and inputs from production personnel, Engineering, or others and incorporating these inputs into the appropriate documentation

KNOWLEDGE, EXPERIENCE & SKILLS

• Technical High School Diploma and 4 years of industrial medical experience, technical publications experience and/or experience in a regulated environment
  An Associate’s Degree and 2 years of industrial medical experience, technical publications experience and/or experience in a regulated environment
  A Bachelor’s Degree in  Graphic Arts,  English or Technical Communication with 0 years of experience
• Experience with Adobe InDesign, Illustrator, and Photoshop strongly preferred.
• Proficiency in Microsoft Office Suite is required.
• Experience with SolidWorks Composer a plus

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).