Quality Engineer II

Xtant Medical Holdings Inc

2024-09-20 17:45:56

Belgrade, Montana, United States

Job type: fulltime

Job industry: Other

Job description

Status: Full Time, Exempt

Reports To: Director of Quality

A. Purpose and Scope of Position

This 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

1. 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
2. Financial Responsibilities
   • Submit timely expense reports and abide by the Expense Reimbursement Policy
   • Maintain strict confidentiality of all company, customer and donor information
3. 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
4. Management
   • This position does not supervise others
   • Work with and support the activities of the Senior Manager of Quality Engineering
5. 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
6. Other duties as assigned
7. 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 HIPAA

1. 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

1. 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 necessary

• N/A

• 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.

• 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.

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