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Job Title: Quality Assurance Specialist
Department: Quality
Reports to: Chief Operating Officer
Classification: Exempt
Position summary:
Experience and strong knowledge of current Good Manufacturing Practice (cGMP) protocols, Food & Drug Administration (FDA)
regulations, and International Organization of Standardization (ISO). Oversees the day to day operations of Quality Control for the
company. Daily tasks would include but are not limited to Quality Management System (QMS) oversight, record review, Standard
Operating Procedure (SOP) creation, internal audits, business development with multiple QMS systems. Works closely with managers to
ensure day-to-day operations are performed to all FDA / Federal regulations and internal standards. Maintains rigorous quality mindset
and advocates strict adherence to compliance practices within the facility. Possesses skills in the medical device industry and cGMP
compliance requirements for storage, initial importer, Customs Border Patrol (CBP) process, internationl shipping, and domestic shipping
ect.
Qualifications required:
 College Degree
 3-4 years Quality Control Experience
 2-4 years FDA Experience
Qualifications desired:
 Bio-medical degree
 Six Sigma
 2-4 years’ experience with ISO 9001 and 13485
 4-6 years’ in a Quality Control position
 5 years FDA Experience
Essential functions and responsibilities:
 Ensures the QMS system is updated, implemented, an adhered to by all employees
 Develops and performs to Operational and Performance Metrics
 Experience doing NCR (non-conformance reports) / QIR (Quality Investigation Reports) / (CAPA) Corrective and preventive
actions
 Knowledge and hands-on experience working with Risk Management and Change Control Systems
 Plans, collaborates, and reviews QMS systems for new business opportunities
 Evaluating multiple entities QMS systems
 Scheduling tasks with new startups to maintain internal and regulatory standards
 Interacts with clients to discuss project planning cross functional QMS procedures
 Interacts with internal staff to identify SOPs and regulatory documents requiring further improvement or development
 Minimal Travel to do site visits of clients as appropriate
 Responsible for appropriately conducting internal audits in accordance with FDA, cGMPs, ISO 9001, and ISO 13485
 Assures company personnel are following all company SOPs and safety rules in compliance with all Federal Agencies
 Prepares and revises technical documents
 Assures that records and other paperwork are completed according to QMS system, cGMPs, and company SOPs
 Project management skills, strong organizational skills, including ability to follow assignments through to completion, initiate
and lead cross functional teams, enhanced skills in leading, influencing and negotiating, strong knowledge in area of expertise,
collaborate and coordinate with higher level outside resources, strong word processing, presentation, database and spreadsheet
application skills, strong communication (both written and oral).
Nonessential functions:
 Engage, interact and respond in a prompt, accurate, courteous and poised manner in order to encourage positive business
relationships
 Consistently demonstrate a positive, constructive, and cooperative attitude in the business environment
Success factors/job competencies:
 Job Knowledge – very well informed, seldom requires assistance or instruction
 Work Output – very few errors and mistakes, quantity is above average
 Reliability – persists in spite of difficulties
 Judgment – thinking is mature and sound
 Initiative and Creativity – a self-starter; proceeds on own with little or no direction; progressive; makes suggestions for
improvement
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Cooperation – goes out of way to cooperate and get along
Attendance – very prompt and regular in attendance; preplanned absences
Professionalism with Customer and Client Focus
Communication - Ability to maintain professionalism in written and oral communication (free of grammatical and spelling
errors)
Time Management - ability to plan and complete projects in a timely fashion, meeting deadlines
Physical demands and work environment:
 Moderate physical activity– Occasional lifting up to 50 pounds, daily sitting at computer for long periods of time