Medical Device Tech - Inspection & Fulfillmen

LocationBelgrade, Serbia | Montana, United States

TypeOnsite

Status:

Full Time – Non-Exempt

Reports To:

Medical Device Technician Team Lead

A. Purpose and Scope of 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.

B. Organizational Relationship

This position reports to the Medical Device Technician Team Lead and/or Manager. This position may provide additional support to other team leads, supervisors, or departments as requested.

C. Duties and Responsibilities

Specific Job Duties/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:

Allocate new inventory from warehouse to fill empty tray items

Transfer items missing in tray to Distributor’s MIA warehouse for invoicing

Update lot numbers in all trays to properly track inventory

Complete all associated documentation and tray second checks before returning to finished goods shelf

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

Financial Responsibilities

Submit timely expense reports and abide by the Expense Reimbursement Policy

Training

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

Management

This position does not supervise others

Work with and support the activities of distribution and fulfillment and other divisions as requested

Document Control and Record Control

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

Performance of Duties

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

D. Job Requirements

Education/Credentials Experience & Training

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

1-year of experience in QA functions and/or manufacturing is preferred, but not required

ERP and automated document control experience is desired

Technical Requirements/Skills

Some knowledge of FDA and ISO requirements as applicable

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

3. Managerial Experience

4. Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications

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

5. Working Conditions

Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm
Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
Work may require occasional weekend/evening work and 4+ hours of continuous standing
Shift times may change based on the current needs of the department
Will operate magnification and inspection/laboratory equipment
Employee may encounter contact with human tissue, blood, bone, and fluids

6. Health and Safety

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.

Note:

This Job Description is not designed to include a detailed listing of the activities, duties or responsibilities that may be required of the employee. This job description does not constitute an employment contract, implied or otherwise, and is subject to change by the employer as the needs of the employer and requirements of the job change.

This position does not offer current or future H-1B Visa Sponsorship

Xtant Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Up to 20 (USD) Hourly