BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Supplier Quality Engineer to work for a leading San Diego biotechnology company.
Sr. Supplier Quality Engineer
The incumbent is responsible for performing all the duties of a Senior Supplier Quality Engineer. Performs tasks with greater scope and minimal oversight from the Supervisor. May assist or supervise other Quality Engineers, technicians and/or administrative personnel in the performance of their duties. 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 external suppliers and internal manufacturing, engineering, regulatory, quality, and materials personnel, and senior management. A positive attitude is important while working in a fast-paced manufacturing environment and dealing with shifting priorities.
Design and maintain the supplier quality management system according to written policies and procedures
Provide quality guidance to other departments.
Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and manage the supplier corrective action system.
Ability to frequently travel in the U.S. and internationally.
Serves as the Chairperson on the Supplier Review Committee (SRC) and ensures ongoing supplier program transparency and open communication between cross-functional departments.
Establishes and maintains the Supplier Audit Schedule and ensures compliance with this schedule.
Serves as the supplier quality representative during internal audits and for designated suppliers, as necessary.
Ensures Quality Agreements are established, where needed, and that any joint periodic business reviews are conducted. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
Works as a member of the design team, as required. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics.
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.
Reads, writes, and understands specifications and inspection criteria.
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).
Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485).
Certified or trained to perform quality audits is highly desired.
Assumes and performs other duties as assigned.
EDUCATION and/or EXPERIENCE
Bachelor's degree from four-year college or university is preferred; minimum 5 years related experience and/or training; or equivalent combination of education and experience.