From designing and leading complex programs to analyzing and translating business capabilities into powerful solutions, your expertise helps shape the future of health care.
Quality Engineer – Optical Laboratory
Los Angeles, California
In this role, you will coordinate quality control and assurance to provide support to all optical lab departments including Stockroom, Surface, Bench, and AR. You will coordinate and manage the Quality Plan (Systems, Documents and Records) and monitor, evaluate, and report QA indicators within optical lab as well as monitor compliance with established internal and external regulatory standards. You will also maintain quality of the laboratory/optical operations and develop and implement SPCs for critical processes and establish process capabilities and control charts. In addition, you will lead and conduct root cause and CAPA process for internal process non-conformances as well as supplier material non-conformances.
At least five years of experience working with an ISO certified medical device manufacturing operation, pharmaceutical or discrete manufacturing operation in a quality engineering, quality, or management role
At least five years of demonstrated working knowledge of ISO 13485 or 9001:2015
A Bachelor’s of Science degree in a relative STEM degree field (science, technology, engineering, or math) or four years of experience in a directly related field with a high school diploma or GED
Lean Six Sigma Green Belt certification
Knowledge of federal, state, and local accrediting agency regulations
The ability to utilize verbal/written/organizational and project management skills as well as interact with all levels of management
Strong interpersonal skills and strong ability to teach/train team members at all levels
The ability to use instruments, techniques, systems, and principles/processes involved in quality control and assurance
Knowledge of optical laboratory operations or medical device manufacturing or discrete manufacturing operations
Statistical skills commonly used in operations and continuous improvement
Proficient with MS Suite
Proficient using internet for collaboration and research
Very high proficiency with Excel
Very high proficiency with Mini Tab
The ability to work in a Labor/Management Partnership environment
The ability to work closely and well on a dynamic and highly experienced management team
Strong business acumen a plus
Preferred Qualifications Include:
Experience with EHS management
Past or present ISO internal auditor certification preferred
Experience leading the development and implementation of an ISO system and certification of such a plus
Knowledge of cGMP a plus
Knowledge of FDA regulations related to medical device manufacturing operations
Knowledge of OSHA/Cal OSHA regulations related to manufacturing operations
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
This position supports Kaiser Permanente’s code of conduct and compliance by adhering to all laws and regulations, accreditation and licensure requirements, and internal policies and procedures.
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About Kaiser Permanente
As America's largest nonprofit health plan, serving over 9 million members in nine states and the District of Columbia, we're driven by the needs of our patients and our responsibility to the communities we serve. We recruit high-caliber individuals and provide them with a positive work environment, outstanding facilities and resources, competitive wages, and exceptional benefits. If you believe quality of care and quality of life go hand in hand, this is the place to put your beliefs into practice.
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