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 - DHR to join our team on-site in Belgrade, MT. It offers a pay rate of $25.75 - $33.11 hourly (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, plus more...
Responsibilities of the QA Technician - DHR:
- Review incoming Device History Records for accuracy, completeness, and conformance in accordance with procedures, and shipping and production schedules.
- Ensure product specifications are met on incoming documentation.
- Perform non-conforming material processes per internal procedures.
- Perform labeling inspection and sampling of products as required by documented procedures.
- Communicate effectively with QC, Fulfillment, and Supply Chain personnel to determine priorities.
- Complete Traceability Documentation associated with ISO and FDA regulations.
- May assist in the development and maintenance of Document Control and Record Control systems that meet FDA, AATB, and ISO standards and regulations.
- Assist in the completion and retention of documentation pertaining to SOPs. Understand the importance of completing and maintaining documents and records without any errors.
- Write and revise a variety of technical documents including SOPs (Standard Operating Procedures), quality standards and specifications, training documents, and inspection and testing protocols as needed and assigned.
- Participate in the completion of Device History Records (DHR).
- Respond to and prioritize requests for Document Numbers, Part Numbers, etc. and maintain adequate records and updating, In-Use Logs as necessary.
Requirements for the QA Technician - DHR:
- AA degree is preferred + one (1) year minimum experience in QA functions and/or manufacturing, preferably in an FDA regulated industry, or equivalent experience
is required. - ERP and automated document control experience is desired.
- Knowledge of FDA, ISO, and AATB quality system requirements as applicable.
- Must have strong written and verbal communication skills and demonstrated customer interaction skills.
- Ability to read engineering drawings as well as interpret and apply GD&T Tolerancing to raw data results is required.
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 standing.
- 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, etc.
- 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.
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.
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.
Compensation details: 25.75-33.11 Yearly Salary
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