Sr Quality Engineer

Position: Sr. Quality Engineer, Req : 6948-1

Location: Irvine, CA (100% onsite)

Duration: 9+ Months Contract

Job Description:

The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer can make engineering drawings, write risk analysis documents and read and interpret drawings.

Education and Experience:

Bachelor's degree in engineering required.

5-7 years of experience required.

Skills:

Creativity, verbal and written communication skills, analytical and problem-solving ability.

Team player and detail-oriented.

Ability to make sketches, engineering drawings and common computations.

Ability to read and interpret blueprints, technical drawings, schematics and computer-generated reports.

Previous experience with computer applications and software related to the engineering field, such as Computer Aided Design (CAD).

Key Responsibilities:

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Lead identification, development, and optimization of complex Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities & implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and reduce overall process/product risk profile.

Oversee prototype builds, train operators and inspectors, develop in-process inspections, validate in-process inspections, manage defect codes, etc.

Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

Develop technical content of risk management files.

Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCAR, CAPA, non-conformances, audit observations) for all supplier production processes and based on engineering principles; analyze results, make recommendations and develop reports.

Train, coach, and guide lower-level employees on more complex procedures.

Oversee Quality support tasks; instruct engineers/technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineers/ technician work.

Other incidental duties

TB EN