Quality Engineer
Commerce, CA 90040 US
Job Description
The qualified Quality Engineer has experience in product inspection and validation documentation of equipment, processes, methods and software.
This position is full-time Mon-Fri 8am-5pm
Located in Commerce, CA.
Duties & Responsibilities
- Serves as a Quality member on new product development (R&D)
- Facilitate design verification test sample size and test method validations.
- Perform analysis of failed material in order to determine the root cause. Implement appropriate corrective actions.
- Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
- Assist R&D in test method development and conduct test method validation.
- Develop and implement quality systems in compliance with ISO certification.
- Develop and improve QC inspection and testing method as needed.
- Assess, process and circulate protocols and final reports for review and approval
- Execute each phase of the validation and/or solicit support to ensure adherence to the protocol requirements.
- Report and document Protocol exceptions
Required Skills & Experience
- Knowledge of statistical analysis software (e.G. MATLAB ) and manufacturing processes
- Experience with medical instrumentation and disposables (i.E. GMPs, ISO9001, ISO13485, etc.).
- Proficient in knowledge of variety of testing equipment ( Introns, pin gages, snap gages, micrometer, caliper, etc.).
- Proficient in Office Windows, Excel, Access, Power Point, etc.
- Knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma and ISO-13485.
- Experience in GMPs, Quality Systems and ISO-13485.
- Understands the Quality System Regulations and ISO standards (13485 and 21 CFR )
- ASQ Certified Quality Engineer Preferred
- Bachelor of Science or related discipline
Please submit your resume for immediate consideration!