At
Xtant Medical, our mission is to honor the gift of donation by allowing our patients to live as full and complete a life as possible. We are seeking a full time, non-exempt QA Technician-Incoming to join our team on-site in Belgrade, MT. It offers a pay rate of $25.75-$33.11/hour and includes the benefits listed below. If you enjoy working as a team and want to grow your career, you've found the right place at Xtant Medical!
Benefits:
- Medical - Dental - Vision
- Generous PTO Schedule
- Corporate Gym Discount
- 401(k)
- Well-Being Programs / LifeBalance Discount Program
- Life & AD&D Life Insurance
- Long-Term & Short-Term Disability
- Tax Savings
- Wellness Apps (Calm & Burnalong)
- And more...
Responsibilities of the QA Technician – Incoming:
This position is responsible for technical aspects of quality including material and product inspection and testing, involvement in product development, and process validation. In addition to these duties, this position creates and reviews documents as well as reports and participates in wide variety of quality tasks in order to maintain a Quality System that meets the standards of FDA CFR Title 21 parts 820 and 1271, AATB, and ISO 13485. This position interacts with employees throughout the company, with other Xtant Medical Divisions, and with a variety of external contacts.This position reports to the QA/QC manager or supervisor and is responsible for communicating effectively with other individuals within all departments.
This position may provide additional support to other supervisors, managers, or departments as requested.
- 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 the 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
- Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
- Represent the company in a professional manner to the public, customers, and vendors, and maintain trusting relationships with physician partners, customers, and fellow employees
- Perform inspections of incoming and returned-from-field products using numerous types of inspection equipment (Smartscope, comparator, calipers, micrometers, etc.)
- Conduct incoming receiving inspection; finished product/certificates of conformance/material certification; document reviews for accuracy and adherence to specifications
- Create nonconformance reports for customer complaints and supplier nonconformances
- Perform first article inspections and communicate results to Supplier Quality
- Participate in part and process testing as part of validations
- Other duties as assigned by management
Education/Credentials, Experience & Training
- Minimum high school diploma or equivalent
- Three (3) years’ medical device industry experience in quality control is preferred
- ASQ Certified Quality Technician; Vocational Training; AA Degree is preferred
Special Requirements/Physical Capabilities or Abilities, other Additional Desirable Qualifications
- Must be able to reason independently and work with moderate guidance
- Ability to interpret data and make sound judgments based on those interpretations
- Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
- Must be able to adapt to quickly changing priorities and schedules
- Must be able to communicate with suppliers and other regulatory agencies as necessary
- Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
- Must possess mobility to work in a standard office setting and to use standard office equipment and to attend meetings at various sites within and away from the office
Working Conditions
- Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work
- Working conditions include normal office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
- Work will require long periods of sitting, standing, and working at a computer
- Duties may include contact with human tissue, blood, bone, and fluids
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
- This position will sometimes be required to wear personal protective equipment (PPE), including laboratory coat, scrubs, and gloves
- Will require experience or training in the routine handling of chemicals and biohazards
- May require OSHA (bloodborne pathogen) training, MSDS/SDS, and other safety training as applicable
- Must be able to lift 60 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.
25.75 To 33.11 (USD) Hourly
