Quality Engineer 2 - Diverse Linx

Job Title: Quality Engineer 2
Location: Irvine, CA//Onsite
Duration: Full Time-Only

JOB DESCRIPTION:

Roles & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local
laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the

duties and responsibilities for this position are:
Working with other functional groups, including R&D and Operations in support of
new product development, engineering projects, quality assurance activities, and
lifecycle management.
Utilizing Quality Engineering tools/processes in development and implementation of
practices for the effective and efficient development, transfer, and maintenance of
products/processes throughout the product lifecycle.
Oversight, from a Quality NPD perspective, of the Non-Conformance Report (Client)
process for BWI facilities located in the U.S.
Develop and establish effective quality control and support associated risk
management plans, AFMEA, DFMEA and PFMEA.
Write, review and/or approve process and product validation protocols and reports,
equipment qualifications, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process
capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments
(DOE), etc.). Performs statistical analysis of data generated including but not limited
to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data
analysis against predetermined acceptance criteria.







Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.