Principal Quality Engineer

Job Title – Principal Quality Engineer

Location - San Diego, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00
1st Shift

Client: Medical Device Company

Job Category: Quality

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Responsibilities
• Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality tools and systems. Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity. Is a core team member for complex design
control / process control projects. Can serve as a CAPA expert.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes. Supports quality system audits.
• Provides input to the management review process
• May perform other duties as required Position-Specific Overview
• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context Contribute to reduce project cycle times, improve effectiveness and
furthering the achievement of goals critical to company objectives

Position specific responsibilities include support of the following, however, are not limited to:
• Design Control
• EU MOD/MOR
• Change control
• Risk Management
• Process Validation
• Identification of CTQ's
• Handling of deviations and non-conformances
• Test method validations
• Supplier qualification
• Post Market Surveillance CAPA- Root cause investigation and implementation of corrective / preventive actions
• Proper Use of Statistics (Sampling Plans)
• Advise on Regulations and standards
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams G Support Internal and external audits Sphere of Influence
0 Work is performed without appreciable direction.
• Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results.
• Plans and participates in disciplines strategically relevant to the business and/or functions
0 Provides advice and mentors junior Associates
• Participates in, and may provide leadership for, multi-disciplinary projects
° Considered Site / functional level Subject Matter Expert.
• May be assigned as site / functional extended team member

Requirements:
• Bachelor's Degree
A minimum of 9 years of relevant experience or a combination of equivalent education and
• relevant experience
Minimum 2 - 3 years of • experience supporting design assurance for medical devices Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.
Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO
14971,ISO 10993, etc.)

Knowledge and Skills:
Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication
• ASQ Certificate(s) desirable (but not required)
• Design for Six Sigma preferred