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.