Quality Specialist

Job Title:

Quality Specialist

Department:

Quality Assurance

Reports To:

Sr. Director QA/QC

Pay Classification:

Exempt

Position Summary:

Responsible for executing the implementation and maintenance of the quality management system requirements for the design and manufacture of in-vitro diagnostic assays and who will support improvement of the system to maintain a high level of regulatory compliance in order to deliver quality product to our customers.

Duties & Responsibilities include but are not limited to:
  • Execute implementation and follow-up of systematic corrective and preventive actions (CAPA) by reviewing adequacy of root cause analysis, corrections, corrective actions, preventative actions and effectiveness Assure the control, security, integrity, and availability of all controlled documentation under the scope of the Quality Management System (QMS), and provides documentation support for all Chembio operations.
  • Participate in compliance (cGMP) audits, customer audits, and vendor audits
  • Conduct internal audits of the Quality Management System
  • Assist in the vendor qualification and evaluation program
  • Develop, maintain and report internal quality systems metrics and trend analyses to management
  • Participate in company committee and / or project meetings
  • Participate in technical transfer activities, including verification of deliverables and deviations/ addenda, document transfer and training.
  • Prepare and / or assist in reports for deviations, CAPA program, customer complaints, and non-conformances
  • Work with cross-functional teams to assist in the development of engineering studies and validation protocols
  • Work with cross-functional teams to assist in Risk Management activities and the compilation of Risk Management reports
  • Support development and implementation of quality related procedures
  • Work on continuous improvement projects to identify root causes and reduce scrap
  • Qualifications Required:
    • Bachelor of Arts or Science; degree in life sciences preferred
    • 3-5 years of practical medical device manufacturing experience preferred, or equivalent experience within quality engineering
    • Working knowledge of ISO quality management system for medical devices (ISO 13485), US FDA Quality System Regulation (21 CFR 820), and relevant international standards (i.e. IVD Directive 98/79EC)
    • Working knowledge of risk management process (ISO 14971) and hands-on experience in risk management tools (FTA, FMEA, Risk Assessment, etc.)
    • Quality Auditor certification is desirable
    • Familiar with Quality sampling and statistical methods.
    • Familiar with validation requirements within the medical device manufacturing environment
    • Excellent verbal skills and ability to demonstrate equally strong written skills
    • Skilled in the use of Microsoft® Office Suite

    For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.