Axogeniscommittedto building and maintaining a strong andgratifyingcompany culture that fosters a work-life balance and professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogenis the leadingcompany revolutionizing thescience of nerve repair.We arepassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contributetopositively impactinglives whileworkingfor a company that respects, recognizes, andvalues allteam members!
Axogenis an equal opportunity employer and does not discriminate against applicantson the basis ofrace, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Axogen is hiring for a Quality Inspector in Burleson, TX!
Job Summary of the Quality Inspector
The Quality Inspector will be responsible for performing quality control (QC) inspection and disposition of materials and products according to specifications. Axogen's products include Medical Devices, Human Tissue-Based Products, components, supplies and labeling materials.
This role will perform QC inspection using measuring instruments (when applicable) and inspection methods. The role ensures any non-conforming materials or products that are identified are managed according to Axogen's Quality System.
The role will also assist the site Quality Operations Team with documentation and records control, including compiling processing batch records for review.
The Quality Inspector is responsible for following all Axogen policies and procedures to ensure compliance with applicable with AATB, FDA, state OSHA and ISO regs and standards. Employees within this role will perform a variety of tasks under limited supervision.
Requirements of the Quality Inspector
High school diploma or equivalent required.
Bachelor's Degree in a Life Sciences and/or in a related field preferred.
Minimum of 3 years of experience in a life sciences field or a related area.
Familiarity with ANSI/ASQ Z1.4-2003, c=0 and AQL methodologies preferred
Experience in an FDA-regulated environment, particularly medical device, human tissue or pharmaceutical manufacturing preferred.
Ability to use basic inspection test equipment such as: digital multimeters, calipers and micrometers.
Working knowledge of Windows and Microsoft Office.
Ability to travel 10% of the time.
Responsibilities of the Quality Inspector
The specific duties of the Quality Inspector include but are not limited to:
Performs Quality Control activities at Axogen's distribution sites. This analyst role will be responsible for incoming material inspections, in-process inspections and finished product inspections, and review of production records for site activities.
The Quality Inspector will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
Quality Inspector will ensure documentation and records at the site are maintained according to Axogen's Documentation and Control Practices. This means records will be precisely organized and quickly retrievable. Records will be accurate, complete and free of errors.
Ensures work is completed productively and effectively both independently and with other departments.
Reports to site Quality leadership
Provides timely, appropriate support and response to the needs of internal and external customers.
Works with internal customers to understand priorities in daily job activities.
Understands the requirements of Axogen's Quality Management System, FDA Regulations and various domestic and international standards. Axogen complies with multiple FDA Regs - Medical Device, Human Cellular, Tissue-Based Products and Biologics/Pharmaceuticals. Axogen also complies with many external regulations and standards, such as ISO 13485, AATB and National Association of Boards of Pharmacy. Axogen also complies with various international and other domestic regulations.
Works closely with site management and colleagues to ensure that operations comply with all applicable requirements (Quality Systems, Regulations and Standards) and in audit readiness standing.
Supports external audits. The Quality Analyst and site Quality leadership will work together with Operations team members to demonstrate to regulatory inspectors and auditors that Axogen's Quality Systems comply with appropriate regulations and standards.
Supports various Quality Management Systems, such as Equipment Calibration and Preventive Maintenance, Internal Audits, Nonconformance and CAPA.
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