Quality Engineer II Second Sight Medical Products
Develops, implements, and maintains Quality Engineering methodologies, systems and
practices. Provide Quality Engineering support in the design, development, manufacture
and servicing of implantable medical devices to ensure that the products conforms to
established specifications and consistently meet or exceed the requirements of our
customers, patients and regulatory agencies.
Essential Duties & Responsibilities:
? Provide quality engineering support to manufacturing. Lead in the implementation
of quality systems, process controls and corrective action systems to meet Quality
policy and external requirements to ensure safe and effective products are
developed and produced. Identifies and implements quality/process control system
to support the development, qualification and ramp-up manufacturing of devices.
? Work with manufacturing engineering to develop master validation plan, process
validation protocols and assure correct execution of the process validation
? Provide quality engineering support to the product development team. Identify and
implement the quality engineering deliverables per Second Sight?s Design Control
policy to insure that the specified design requirements are met. Work with project
team to develop and review design verification and validation protocols/reports.
? Participate in Material Review Board. Identify non-conformance trends and lead the
investigation to solve the problem. Identify non-conforming trends, prepare Quality
metrics periodic reports and develop investigation plans if applicable. Review and
approve the disposition of non-conforming product.
? Assist in the development and assessment of Second Sight?s Supplier Evaluation
Program; address problems and recommend solutions to supplier quality; interface
sufficiently to ensure product specifications are met at supplier.
? Review document control changes to products, process, software and other
changes for reliability/quality impact.
? Assist with the Calibration and Preventive Maintenance of equipment in compliance
with Second Sight?s Standard Operating Procedures. Develop calibration methods
and frequency for new gauges and equipment.
? Lead in the implementation of quality engineering practices, process controls and
CAPA system to meet or exceed product and system requirements. Assist in the
implementation of SSMP Document Control Policies and procedures.
? Plan and conduct requested audit of specific processes or areas to include
investigation, evaluation and follow-up.
? Review and approve lot history records to ensure product compliance with
specifications and regulatory requirements.
? Backfills for other Quality Engineers as required. Qualifications:
o A Bachelor?s Degree (or higher) in Engineering Science or related field.
Related professional experience may be considered in lieu of education..
? Experience Required:
o Requires 3-5 years medical device experience, or highly regulated industry,
with working knowledge of quality systems requirements. Higher education
in related discipline may be considered in lieu of experience.
? Required Knowledge:
o Ability to read, understand and execute quality procedures.
o Knowledgeable of GMP and ISO requirements.
o Knowledgeable with the principles of root cause analyses, validation and
o Good interpersonal skills.
o Effective written and oral communication skills.
o Computer skills - proficient in web-based applications, spreadsheet, word
o Working knowledge of design assurance, including DOE, FMEA, Fault tree
analyses and risk management desirable.
o Excellent people skills, team oriented
o Effective written and verbal communication and organizational skills
||12744 San Fernando Road |
Sylmar, CA 91342