Quality Engineer II
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 position will develop new and
existing processes to incorporate Quality, ensure Quality Assurance
capabilities upon implementation, and maintain/improve processes
post-implementation. This position will also ensure that Design
Controls, including Risk Management, are adhered to throughout all
development activities (new products, new processes, & process
improvements). This position interacts with employees in Operations
and may interact with other department managers, supervisors, and
employees. This position ensures that Xtant 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 and may provide additional
support to 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 Support of manufacturing activities from a Quality
Engineering perspective in accordance with the requirements of 21
CFR 820, 21 CFR 1271, ISO 13485, and MDSAP (per jurisdictional
areas)
- Communicate effectively with suppliers to resolve incoming
documentation and quality issues
- Work with all departments and divisions within Xtant to ensure
adherence to Xtant's Quality Management System
- Support Manufacturing activities from a Quality perspective in
accordance with the requirements of 21 CFR - 820, 21 CFR - 1271,
ISO 13485, and MDSAP (per jurisdictional areas)
- Perform Design Control activities such as Risk Management,
trace matrixes, Verification & Validation, providing Quality input
for design specifications, developing workflows, writing work
instructions and SOPs, gate reviews, etc.
- Conduct validations, to include plans, protocols, reports,
serving as a liaison-consultant to engineering and manufacturing
teams throughout the design control process
- Support existing product/process development by evaluating data
from production, NCs/Complaints (with root cause investigation),
and engineering studies. Drive for improvement by implementing
meaningful process changes
- Lead efforts to identify quality gaps in the design of
manufacturing-related processes and systems. Implement process
improvements where quality is inherent, relevant, and effective
within the processes. Develop new workflows that ensure quality
throughout by implementing QC metrics within processes that
minimize/eliminate preventable failure modes
- Participate as a team member on product and/or process
development projects.
- Identify areas of opportunity for continual improvement and
lean manufacturing throughout the facility
- Support the efforts of QA/RA Management to achieve departmental
goals and quality objectives
- Manage and maintain Xtant Medical's Design History Files &
associated processes
- Manage and maintain Xtant Medical's Risk Management Files &
associated processes
- Participate in the following QMS activities:
- Nonconforming Product Management
- Supplier Management
- Corrective and Preventive Actions
- Internal and External Audits
- Sterilization Validation/Dose Audits
- Other QMS activities such as batch record review and product
inspection (as applicable)
- May concurrently manage multiple projects and/or serve as the
lead for these projects
- Financial Responsibilities
- Submit timely expense reports and abide by the Expense
Reimbursement Policy
- Maintain strict confidentiality of all company, customer and
donor information
- 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
- Maintain required training documentation
- Complete annual SOP review and OSHA safety training as
applicable
- Train and monitor 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 the Senior Manager of
Quality Engineering
- Document Control and Record Control
- Assist in the completion and retention of documentation
pertaining to all Device History File (DHF) and Change Management
records 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
protocols, work instructions, standard operating procedures, forms,
specifications, and training documents
- 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, including initial orientation and
environmental health and safety training, prior to performing
tasks. Keep training up to date
- 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 and
follow requirements to properly dispose of hazardous and
non-hazardous waste according to OSHA regulations and Xtant Medical
SOPs
- Must maintain confidentiality of donor and recipient
information according to HIPAAD. Job Requirements
- Education/Credentials Experience & Training
- Minimum of a Bachelor's degree from an accredited college or
university in Engineering or related technical field of study
- Minimum of four (4) years' experience in a Quality role,
preferably in the Medical Device, Biologics, and/or pharmaceutical
industries
- Minimum of one (1) year of experience leading and executing
Medical Device Risk Management and Design Control processes
- Quality certifications (e.g., CQT, CQPA), Lean manufacturing
and/or Six Sigma certifications are preferred
- Technical Requirements/Skills
- Advanced knowledge of FDA, ISO, & AATB regulations and guidance
(e.g., Design Controls, Risk Management, GxP)
- Must possess excellent organizational skills and attention to
detail, ability to effectively communicate, and a strong aptitude
for problem solving
- Technical writing proficiency for creating, reviewing,
approving protocols/reports, work instructions, forms, and
SOPs
- Advanced knowledge and experience in biologics manufacturing or
other relevant cleanroom/aseptic environments. Advanced knowledge
of volume and routine-manufacturing operations
- Proficient computer skills required such as basic knowledge of
MS Word, Excel, PowerPoint, Outlook, and other software as
necessary3. Managerial Experience
- N/A4. Special Requirements/Physical Capabilities or Abilities,
other Additional Desirable Qualifications
- Must be able to work independently with minimal guidance. Must
be a team-player, able to constructively engage with
cross-functional associates. Able to effectively work with external
vendors, partners, agencies etc. as necessary.
- Able to work in a standard office setting, use standard office
equipment, and to attend on-site and off-site meetings. 5. 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
- 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.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
- 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
- Must be able to lift 20 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.
Compensation details: 70000-90000 Yearly Salary
PI9c2c37d2bc6c-37248-33730781
Keywords: Xtant Medical, Bozeman , Quality Engineer II, Engineering , Belgrade, Montana
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