Supplier Quality Engineer
Company: Xtant Medical
Location: Belgrade
Posted on: September 18, 2024
Job Description:
Status: Full Time - ExemptReports To: Director of QualityA.
Purpose and Scope of PositionThis person will not supervise others
but will support the activities of QA/RA Management. This position
interacts with employees in the Department and may interact with
other Department Managers, Supervisors, and employees. This
position helps ensure that Xtant Medical complies with and meets
the standards of the FDA, AATB, ISO 13485, and other regulatory
agencies as necessary.B. Organizational Relationship This position
reports to the Director of Quality, supports the activities of the
QA/RA department, and may provide additional support to supervisors
or other departments as requested.C. Duties and
Responsibilities
- Specific Job Duties/Responsibilities
- 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
- Financial Responsibilities
- Maintain strict confidentiality of all company, customer, and
donor information
- Submit timely expense reports and abide by the Expense
Reimbursement Policy
- Training
- 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
- Management
- 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
- 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
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
- Other duties as assigned
- Performance of Duties
- 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 HIPAAD. Job Requirements
- 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
conclusions3. Managerial Experience
- N/A4. 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 office5. 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 levels6.
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 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.
Compensation details: 70000-90000 Yearly Salary
PI8b1d1da08740-37248-33730779
Keywords: Xtant Medical, Bozeman , Supplier Quality Engineer, Engineering , Belgrade, Montana
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