The Quality Inspector will be responsible for inspecting materials and products for conformance to specifications using fixed or pre-set measuring instruments. Ensures materials and products are in accordance with established tolerance levels for quality and performance and are not irregular or damaged. Responsible for ensuring all policies and procedures are in compliance with applicable FDA, state, OSHA, and ISO regulations and standards. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under limited supervision. The job requires the individual to be a team player with the ability to function well in a challenging and fast paced environment. Must be positive, even tempered and have strong skills in areas of dependability, flexibility and maturity.
The Quality Inspector will be in contact with human tissue products and will be expected to perform inspection of human tissue products to ensure the product meets specifications. The Quality Inspector may be required to work in controlled environment and be proficient in gowning practices and understand aseptic technique practices
The specific duties of the Quality Inspector include but are not limited to
Responsible for Quality Control activities at AxoGen’s Satellite facilities.
Inspector will be responsible for receiving inspections, in-process inspections, and finished device inspections.
The inspector will maintain accurate and complete records of Quality Control Activities.
Inspector will maintain Quality Records for the satellite facility in an “audit-ready” state.
Inspector will be responsible for ensuring records meet Good Documentation Practices meaning records will be precisely organized and quickly retrievable, records will be accurate, complete and free of errors.
Able to work productively and effectively both independently and with other departments.
This position will report to the Quality Management at Corporate headquarters, and this person will work directly with personnel in the satellite facilities.
Provide timely, appropriate support and response to the needs of internal and external customers. Work with internal customers to understand priorities in daily job activities.
Understand the requirements of AxoGen’s Quality Management System, FDA Regulations, and various domestic and international standards. AxoGen complies with multiple FDA Regulations – Medical Device, Human Cellular- and Tissue-Based Products, and Biologics/Pharmaceuticals. AxoGen also complies with many external regulations and standards, such as ISO 13485, American Association of Tissue Banks (AATB), and National Association of Boards of Pharmacy. AxoGen also complies with various international and other domestic regulations.
Work closely with AxoGen Management Team and AxoGen staff to ensure that operations are in compliance with all applicable requirements (Quality Systems, Regulations, and Standards) and in audit readiness standing.
Support external audits. Inspector and Quality Management will work together to demonstrate to inspectors and auditors that AxoGen’s systems are in compliance with appropriate regulations and standards.
Support various Quality Management Systems, such as Document Control, Equipment Calibration and Preventive Maintenance, Internal Audits, Nonconformance, and CAPA.
Requires a high school degree or its equivalent with at least 2 years of experience in the field or in a related area.
Excellent oral and written communication skills.
Familiarity with ANSI/ASQ Z1.4-2003, c=0 (Zero Acceptance Number Sampling Plans by Squeglia).
Familiarity with GMP environment; reading & checking Bills of Materials, schematics, and machine/assembly drawings.
Ability to use basic inspection test equipment such as: multi-meters, calipers, CMM, bore & ID gages, depth and height gages, etc.
Working knowledge of Windows and Microsoft Office
Ability to travel up to 10% of the time
Ability to work under minimum supervision with a high degree of organizational and technical competence
Ability to function well under pressure and expend effort to meet schedules and deadlines
It’s time to rethink nerve repair.™
AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular m...atrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.