Quality Engineer

Job Title:

Quality Engineer

Department:

Quality Assurance

Reports To:

Senior 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
  • 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
  • Manage non-conforming material and dispositions
  • Develop, maintain and report internal quality metrics and trend analyses to management
  • Participate in company committee and / or project meetings
  • Prepare and / or assist in reports for deviations, CAPA program, customer complaints, and non-conformances
  • Participate in scale-up activities and product and process validation activities.
  • Develop validation master plans/project plans (VMP), revalidation plans and standard operating procedures (SOP) as required.
  • Assist in the development, design, and validation of new manufacturing processes.
  • 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.)
  • Six Sigma knowledge and Quality Auditor certification is desirable
  • Familiar with validation and calibration 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.