Responsible for executing the Quality Assurance functions of the facility, including but not limited to Quality policies, procedures, and programs to ensure compliance to the FDA, customer specifications, and customer satisfaction. Promote positive relations with the production team to enhance the Quality culture and awareness.
JOB DUTIES AND RESPONSIBILITES:
Ensure quality control functions are performed per the written Standard Operating Procedures and GMP
Assist with the facility training of employees, annual updates, and other required instruction as needed. Programs include but are not limited to bloodborne pathogens, lock-out tag-out, right to know, and evacuation procedures
Assist with the maintenance of the Medical Device Records log, distribution, and control of all related documents
Maintain sterility release records and coordinate the release of individual loads and disposable accessory packs
Assist with the product complaint program as directed by the Quality Manager
Perform floor inspections, shipping and receiving, final inspections for medical devices
Audit job performances to ensure SOP/GMP compliance
Assist with bioburden and airborne environmental sampling
Perform other duties as assigned
WORKING CONDITIONS:
Indoor facility environment with occasional exposure to uneven temperatures, bio-hazardous materials, and strong odorous chemicals, along with other elements
Travel required 0% of the time
EXPERIENCE, KNOWLEDGE, AND SKILL REQUIREMENTS: (List the minimum requirements for the position.)
Willing to train the right candidate
Prefer some familiarity with FDA and Medical Devices
Prior experience internally to Novo Health Services will be considered in place of direct previous quality assurance responsibilities
Detailed-oriented
Ability to manage time and work with minimal supervision
Excellent verbal and written communication skills
Flexible in work hours
Ability to read and understand applicable Standard Operating Procedures
Proficient in Microsoft Word and Excel
EDUCATION AND TRAINING REQUIREMENTS:(List the minimum requirements for the position.)