PRINCIPAL QUALITY ENGINEER Second Sight Medical Products
Recognized as Quality expert within company. Develops implements and maintains Quality
Engineering methodologies, systems and practices which meet Second Sight quality, reliability
and regulatory requirements. Relies on critical judgment to plan and accomplish complex goals.
Provides Quality Engineering consulting support in the design, assurance, quality tools, and
Quality Systems to ensure that the products and Systems conform to established specifications
and consistently meet or exceed the requirements of our customers and patients. Directs and
coordinates activities of QC Inspector. Exhibits a wide degree of creativity and latitude in
performing difficult tasks.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Implement or lead the implementation of difficult and/or complex quality initiatives to
support the departmental and company goals and priorities.
? Perform in depth technical risk assessment and review new development projects
and design/process changes at defined design reviews in the project plan or at QE
ETQ document review phase.
? Identifies and implements quality/process control system to support the
development, and ramp-up manufacturing of devices working jointly with R&D and
? Lead in the implementation of the process controls and Quality Assurance system
? Provide technical guidance on the use of Quality Engineering methods and tools for
identifying and resolving quality issues, including CAPA activities.
? Participate in 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 resolve non conformances and quality issues.
? Assist in the development and assessment of Second Sight?s supplier control
program; address problems and recommend solutions to supplier quality; interface
sufficiently to ensure product specifications are met; perform supplier audits.
? Direct and coordinate activities of subordinate and assist subordinate in attaining
? Carries out supervisory responsibilities in accordance with the organization?s policies
and applicable laws. Responsibilities include interviewing, hiring and training
employees; planning, assigning, and directing work; appraising performance;
rewarding and disciplining employees; addressing complaints and resolving
? Provide back-up inspection including the use of SmartScope.
? Manage the planning, coordination, and implementation of internal audit program to
assess compliance with FDA/ISO/AIMDD & SSMP requirements. Develop audit
schedules, schedule audits, perform audits, write audit reports, and follow audits to
closure. Train other internal auditors.
? Act as Subject Matter Expert for Sterilization.
EDUCATION/CERTIFICATION: BS degree in Engineering or related discipline preferably with
Master?s in related engineering field. ASQ CQE, CQA, CRE, or CBA is a plus.
EXPERIENCE REQUIRED: 6 plus years experience as a Quality Engineer in the medical
device industry or in a related area. Or equivalent combination of education and experience
with ASQ CQE certification. A minimum of 1 to 3 years experience in compliance auditing in
medical device or comparable environment.
? Applies regulatory requirements such as FDA QSR, European Active Implant
Medical Device Directive and other regulatory requirements. Generate procedures in
compliance with regulations.
? Have knowledge of statistical techniques and quality tools with proper application of
? Ability to apply ISO/EN Sterilization and Biocompatibility standards and guidelines
? Training in audit techniques
? Excellent people skills, team oriented
? Excellent problem-solving skills
? Effective written and verbal communication and organizational skills
? Be able to coach others or teach the proper use of quality tools and problem solving
||12744 San Fernando Road |
Sylmar, CA 91342