Medical Device Tech - Inspection & Fulfillmen

Xtant Medical Holdings Inc•Belgrade, MT

35d

About The Position

This position will perform activities related to inventory fulfillment, quality maintenance, and regulatory compliance in their department, as assigned. This person does not supervise others but will support the activities of the Medical Device Technician Team Lead and/or Manager. This position works with the department team lead and manager and with other technicians at the fulfillment and distribution level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA) and International Organization of Standardization (ISO), and other regulatory agencies as necessary in distributing Xtant Medical inventory.

Requirements

High School Diploma or equivalent is required
Professionalism and strong communication skills
Attention to detail and quality control
Basic knowledge of ISO 13485 Medical Devices – Quality Management System and FDA 21 CRF Part 820 Quality System Regulation
Experience with manufacturing related Inventory Control software
Ability to manage multiple tasks but maintain focus to finish job to completion
Effectively utilize PC applications to complete required job function
Understands sense of urgency in a fast-paced environment but commits to quality over quantity
Strong initiative and leadership skills needed
Demonstrated capability to communicate effectively both orally and in writing
Ability to multitask
Must possess excellent organizational skills and strong attention to detail
Basic computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
Ability to investigate and analyze data to draw conclusions and drive solutions
Experience with records maintenance and document control needed
Must be able to reason independently and work with guidance
Ability to interpret data and make sound judgments based on those interpretations
Must be able to adapt to quickly changing priorities and schedules
Strong attention to detail with a drive for organization
Able to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
Must have excellent manual dexterity and good eye/hand/foot coordination
Must adhere to all health and safety requirements specified when entering laboratory and device manufacturing areas and in the handling of company products
May require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver
Must be able to lift, push, and pull 80 lbs.

Nice To Haves

1-year of experience in QA functions and/or manufacturing is preferred, but not required
ERP and automated document control experience is desired

Responsibilities

Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO) 13485; European Medical Device Directives (MDD); and Canadian Medical Device Regulations as applicable and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
Adhere to Xtant Medical Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
Develop and maintain an understanding of Xtant Medical products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
Complete annual SOP review and OSHA safety training
Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant Medical SOPs
Perform Quality Control (QC) as required by SOPs
Assist with managing inventory warehouse counts utilizing cycle count program
Follow OSHA bloodborne pathogen standards, universal precautions, AATB Standards, and current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP) during all phases of processing packaging, storage and cleaning
Daily Product Transaction Activities – inventory allocation within an ERP system, tracking and reconciling inventory returns to match finance and invoicing
Maintaining tray inspection throughput to provide necessary inventory redistribution within a timely manner
Receiving/Inspecting/Reprocessing of Surgical Sets and Reconciling Associated Documentation
Building of Sets for Product Launches and Reconciling Associated Documentation
Identifying Material Storage & Stock Locations
Track Material with Limited Shelf Life or Expiration Dates to appropriately discard inventory if within expiration window
Processing of returned trays from field: 1. Allocate new inventory from warehouse to fill empty tray items 2. Transfer items missing in tray to Distributor’s MIA warehouse for invoicing 3. Update lot numbers in all trays to properly track inventory 4. Complete all associated documentation and tray second checks before returning to finished goods shelf 5. Report missing inventory items to invoicing to verify billing and transact records
Upon hire, employee may rotate through support departments in order to learn various aspects of the department including decontamination, picking orders, packaging orders, shipping, product labeling and inventory decontamination
Employee shift schedules may vary depending on the needs of the department and high peak order times
Quarter and Year End dates are MANDATORY working days and will be outlined at the beginning of every fiscal year for the team to schedule vacation around
Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with physician partners, customers, and fellow employees
Submit timely expense reports and abide by the Expense Reimbursement Policy
Participate in training plans and programs and complete in a timely manner within set deadlines
Complete required training prior to attempting to perform a task
May be asked to travel to complete LIVE training and job shadowing
Work with and support the activities of distribution and fulfillment and other divisions as requested
Assist in the completion and retention of documentation pertaining to all SOPs as required
Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
Write and revise a variety of technical documents including contracts, non-disclosure agreements, SOPs, and training documents as needed and assigned
Maintain information in physical and electronic files as required
Train on and demonstrate proficiency in Xtant Medical’s document control system
Other duties as assigned
Complete required training prior to performing tasks, including initial orientation and environmental health and safety training
Perform all duties according to established procedures and follow appropriate safety precautions and measures
Conduct himself/herself in a professional and courteous manner in all aspects of interaction with fellow employees, surgeons, staff, and end users
Maintain a clean and safe working environment at all times
Must maintain confidentiality of donor and recipient information according to HIPAA