Sr. Quality Assurance System Specialist

Title: Sr Quality Assurance Specialist
Location: Peachtree Corners, GA, 30071
Duration: Permanent Placement
Compensation: 70-80k
Work Requirements: US Citizen, GC Holders

Qualified candidates may send a copy of their resume (Word Format) to Elizabeth Walton at ewalton@inspyrsolutions.com. 

Job Description:
Responsibilities:
The Quality System Specialist is responsible for ensuring compliance to all applicable regulatory standards through review of all Device History Record documentation. Responsibilities will include review and approval of documentation for serological, chemical and biological evaluations completed on final, intermediate and raw material products and for filling, labeling and packaging operations to ensure product meets specifications prior to distribution. Strict attention to detail and familiarity with standard concepts, practices and procedures is required.

Specific duties for this manufacturing operations compliance role include:

• Executes batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Ensure accuracy, integrity and completion of every page, reconciliation, and product yield computation
• Identify mistakes, oversights, and incomplete data on batch records and reports batch record deficiencies to Manufacturing for correction.
• Ability to work under pressure in a fast paced environment, independently without close supervision.
• Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485 is required.
• Thoroughly understands regulatory requirements including domestic and international standards applicable to the company and consequences of non-conformance . This includes but not limited to FDA regulations, ISO 13485, Canadian Medical Devices Regulations, and In Vitro Diagnostics Directive.
• Writing, standard operating procedures, change orders, document change requests, and corrective/preventive action requests.
• Thoroughly understands company policies and has basic understanding of activities of all company departments.
• Demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to quickly drive solutions while maintain positive relationships. 
• Represent the Sr. Quality Operations Managers and/ or Quality Operation Managers in a variety of forums such as: FMEA exercises, deviation investigations, commercialization teams, Triages and others as deemed necessary.
• Make quality decisions including but not limited to determination of a quality deviation, Product hold and disposition, etc. based on the specific circumstances that could affect product quality.

Sr. Quality Assurance System Specialist (Manufacturing Compliance / Systems QA)

Qualifications:
Specific qualifications for this medical device quality assurance role include:

• Bachelor's degree (BS/BA) from four-year college or university; or equivalent combination of education and experience or 5+ years of experience in a comparable manufacturing environment
• Experience/certification as a medical technologist is required.
• Computer proficiency including MS Office Suite
• Intermediate mathematics skills
• Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485, as well as Canadian Medical Devices Regulations, and In-Vitro Diagnostics Directive
• Ability to adhere to Regulatory and Compliance Standard operating procedures