Senior Quality Engineer Second Sight Medical Products

We are searching for an accomplished, organized and self-motivated Senior Quality Engineer. This position is responsible to develop, implement and maintain quality engineering methodologies, systems, and practices which meet Second Sights quality and regulatory requirements. It will provide quality engineering support in the design, development, manufacture and servicing of Second Sight products to ensure that the products conform to established specifications and consistently meet or exceed the requirements of our customers. This position will ensure that Second Sight documents and document control records comply with Document Control policies and procedures.
Essential Duties & Responsibilities: (relating primarily to the external parts of the system)
Implement or lead the implementation of quality initiatives to support the departmental and company goals and priorities
Identify and implement quality/process control system(s) to support the development, validation and verification, and manufacturing of devices
Provide technical guidance on the use of quality engineering methods and tools for identifying and resolving quality issues
Participate in the Material Review Board; review and approve the disposition of non-conforming product
Identify non-conformance trends and opportunities for quality improvements; proactively investigate and implement quality engineering practices to quality issues
Assist in the development and assessment of Second Sights Supplier Evaluation Program; address problems and recommend solutions to supplier quality; interface sufficiently to ensure product specifications are met
Provide quality engineering support within the product development, manufacturing and services; lead in the implementation of quality assurance and quality engineering methodologies
Qualifications:
Education / Certification:
o BS degree in Engineering or related discipline preferably with Master in related engineering field
o Electrical Engineering or Computer Science backgrounds are preferred
o ASQ, CQE, or CRE is a plus
Experience:
o 4-6 years experience as a Quality, Reliability or Software Quality Engineer in the implantable medical device industry or a related area
o Experience with active implantable medical device software, firmware, and hardware
o Demonstrated ability to plan and accomplish complicated goals desired
Required Knowledge:
o Applies regulatory requirements such as FDA QSR, European Active Implantable Medical Device Directive, and other regulatory requirements
o Generate procedures in compliance with regulations
o Comprehensive knowledge of Quality Engineering, Quality System Management, Document Control and application of statistical techniques
o Knowledge of electronics assembly desirable
Skills & Abilities:
o Excellent people skills; must be team oriented
o Effective written and verbal communication and organizational skills
o Ability to effectively mentor others or teach the proper use of quality tools and problem-solving techniques

Location:	12744 San Fernando Road Building Three Sylmar, CA 91342 United States