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, exempt Supplier Quality Engineer to join our team on-site in Belgrade, MT. It offers a pay rate of $70k - $90k DOE 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 Supplier Quality Engineer:

Develop and maintain an understanding of the requirements of the applicable standards and regulations including, but not limited to, 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485. Adhere to and promote compliance with the applicable standards and regulations throughout the company
Support Xtant Medical’s mission, values, and Quality Policy
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
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
Adhere to Xtant Medical Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and safety protocols
Complete annual SOP review and OSHA safety training as applicable Work with all departments and divisions within Xtant Medical to ensure understanding of and adherence to Xtant Medical’s Quality System
Manage Supplier Qualification activities, including but not limited to, initial qualification, re-qualification, SCAR issuance, supplier qualification termination, etc.
Plan and conduct regular audits with suppliers including onsite qualification of product and processes. Write audit reports to disclose findings, Present findings as needed. Maintain and update critical supplier audit system and schedule
Support new supplier evaluation and qualification including inspection and first articles
Measure, analyze, and improve supplier performance and reduce supplier nonconformances
Work to resolve supplier technical issues in a timely manner to ensure continuity of supply
Conduct receiving inspections, in-process inspections and finished device inspections
Inspecting and monitoring receiving, in-process, and final product control results including collection and testing of representative samples
Participate in and help lead successful external audits (FDA, ISO, etc.). Serve as a liaison between QA/RA Management and the auditor(s) during regulatory inspections
Perform and participate in validations as needed
Participate in design control as needed
Help to accomplish quality objectives and develop quality standards
Perform and manage Internal Audits as directed by QA/RA Management
Participate in Complaint, Deviation, Nonconformance, and CAPA investigations as necessary
Support the efforts of QA/RA Management to achieve departmental goals and quality objectives
Maintain strict confidentiality of all company, customer, and donor information
Submit timely expense reports and abide by the Expense Reimbursement Policy
Complete required training prior to performing tasks, including initial orientation and environmental health and safety training. Keep training up to date
Perform annual training including but not limited to Annual SOP review, Annual Bloodborne pathogen training, etc.
Train and supervise the training of others in Department activities
May review and maintain employee training records
This position does not supervise others
Work with and support the activities of QA/RA Management
Help direct the activities of Department employees to accomplish quality and company objectives
Assist in the hiring of skilled, responsible, and ethical individuals for the Department as necessary
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 information 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
Perform all duties according to established procedures and follow appropriate safety precautions and measures
Represent the company and conduct himself/herself in a professional and courteous manner in all aspects of interaction with the public, customers, vendors, 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

Education/Credentials Experience & Training

Bachelor's degree in biology-related, engineering or an equivalent course of study is required
Five plus (5+) years’ experience in medical device, biologics, orthopedic or health industry quality assurance is preferred
Corrective/preventive action, root cause analysis, effectiveness check, statistical application experience and training is required
ISO 13485 Lead Auditor Certificate is preferred
ASQ Certified Quality Auditor Certificate is preferred
Six-sigma black-belt certification is preferred
General knowledge of ISO 13485 and FDA Quality System Regulation guidelines required, advanced knowledge is preferred
Regulatory and Quality auditing training and experience is required
Experience and high level of proficiency in Microsoft Office Suite is required
- Experience with records maintenance and document control
- Experience in regulatory standards, regulatory inspection hosting, GLP, GMP and GDP
- High level of attention to detail and accuracy is required
- Strong organizational skills and ability to prioritize tasks is required
- Exceptional documentation and technical writing skills is required
- Excellent verbal and written English language skills is required
  - Knowledge of FDA, ISO, and AATB requirements
  - Ability to write, review, and edit technical reports and SOPs
  - Must possess excellent organizational skills and strong attention to detail
    - Ability to lead and influence others to drive change (cross-functionally and globally)
    - Superior problem-solving skills, and the desire to help find solutions to internal and external customer needs
    - Proficient computer skills required such as basic knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
    - Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups
    - Ability to assist in the development and presentation of educational programs and/or workshops
    - Strong leadership and interpersonal skills and the ability to effectively communicate with a wide range of individuals in a diverse community
      - Ability to investigate and analyze information and to draw conclusions

Managerial Experience

N/A

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

Must be able to reason independently and work with minimal supervision
Ability to interpret data and make sound judgments based on those interpretations
Ability to react quickly and adapt to changes in priorities, schedules, circumstances and direction is required
Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
Ability to maintain good working relationships with all co-workers, the general public, and outside contracts is required
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

Working conditions are normal for an office environment. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work and travel
Up to 50% travel is required
Work may require long periods of sitting, standing, and working at a computer
Working conditions may include a laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments
Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks as necessary
May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels

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, etc.
Will require experience or training in the routine handling of chemicals and biohazards
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

About Us:

We aim to improve the quality of life for our patients by designing, manufacturing and distributing medical devices and human tissues for transplants that are safe, effective and meet the needs of our customers.

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.