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Quality Assurance Specialist
2 months ago
Job Summary:
Xtant Medical Holdings Inc is seeking a highly skilled Quality Engineer II to join our team. As a Quality Engineer II, you will be responsible for developing and maintaining an understanding of the requirements of applicable standards and regulations, including 21 CFR 820, 21 CFR 1271, AATB, MDSAP, and ISO 13485. You will ensure compliance with these standards and regulations throughout the company.
Key Responsibilities:
- Develop and maintain an understanding of the requirements of applicable standards and regulations.
- 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 Xtant Medical products and general biological and chemical systems utilized within the Department.
- 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 manufacturing activities from a Quality Engineering perspective in accordance with the requirements of 21 CFR 820, 21 CFR 1271, ISO 13485, and MDSAP.
- 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.
- 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.
Requirements:
- 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.
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.
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.
