Sr. Quality Assurance Engineer

Sr. Quality Assurance Engineer Job Description Template

Our company is looking for a Sr. Quality Assurance Engineer to join our team.

Responsibilities:

  • Represent QA on development, current business or product improvement projects. Assure accuracy of product labeling and compliance;
  • Accept/reject advertising, technical product, and support literature. Identify and/or perform vendor audit or site visits;
  • Provide design review and risk assessment expertise;
  • Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments;
  • Provide input to budget process and project schedules;
  • Provide input in Customer Feedback failure investigations;
  • Review, implement, or revise product, project, and program quality activities;
  • Generate, prepare and issue complex data for assigned quality reports;
  • Approve the design, implementation, and schedule for QA projects;
  • Initiate, recommend, and provide training for QA personnel;
  • Develop, review and approve validations and completion reports for new and existing products, processes and equipment;
  • Complete all assigned and required training satisfactorily and on time;
  • AbelConn is ISO 9001 and AS 9100 registered, and Nadcap accredited; all job duties are to be performed per the documented work instructions;
  • Prepare monthly and quarterly trending, including Statistical Process Control documentation, and support the Quality Management Review Process;
  • Supplier interface: Develops and maintains good working relationships with suppliers. Coordinates requests for corrective action when necessary.

Requirements:

  • Lead Auditor certification;
  • Experience in biomedical research instrument or medical device manufacturing;
  • Certified Quality Engineer or Reliability Engineer;
  • Hands-on experience in statistical analysis;
  • Broad knowledge of a general technical field such as quality assurance or quality engineering;
  • Demonstrates knowledge of statistical sampling and analysis;
  • Demonstrates excellent organizational, communication, and project management skills;
  • Able to prioritize projects to meet organizational goals and objectives;
  • BS Degree in Engineering or related field;
  • 7 to 10 years of quality assurance experience;
  • Education : Bachelor’s Degree in engineering preferred (Biomedical, mechanical, chemical, or electrical) or Science (Biology);
  • Proficient with the MS Office Suite, and statistical software;
  • Experience : 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing;
  • Certifications: ASQ CQE preferred;
  • Must be able to work independently with minimal supervision.