BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Quality Engineer to work for a leading San Diego biotechnology company.
Sr. Quality Engineer
The incumbent is responsible for performing all the duties of a Quality Engineer. Leads / Performs tasks with greater scope and minimal direction from Management. May also supervise and administer specific aspects of the quality system. The incumbent will be systematic, highly organized and articulate and work in a team environment. Job tasks require interfacing with manufacturing, engineering, regulatory, materials personnel and senior management. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.
May supervise and administer specific aspects of the quality system.
Provide quality guidance to other departments.
Develops systems and performs quality function that help the company achieve its quality policy and compliance with regulations. Some examples of the systems include (support CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training).
Works as a member of the design team in R&D. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
Employs the techniques like six sigma, lean manufacturing and TQM to improve operations.
Takes the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
Works with a variety of inspection techniques and acceptance sampling plans such as ANSI/ASQ Z1.4, Z1.9 and C=0.
Coordinates the disposition of nonconforming materials with the materials review board.
Reads, writes, and understands specifications and inspection criteria and to apply criteria using appropriate and properly configured inspection tools.
Reads schematics and mechanical drawings.
Works and communicates effectively and professionally in a team environment with minimal supervision.
Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle, Agile, and MiniTab).
Assumes and performs other duties as assigned.
EDUCATION and/or EXPERIENCE
Bachelor's degree (B. A.) from four-year college or university; 10 to 15 years related experience and/or training; or equivalent combination of education and experience.