Job Title: Sr Quality Engineer
Pay Rate: $60 to $65.67/Hr
Duration: 9 Months
Location: Irvine, CA (Onsite)

Shift - 8 AM to 5 PM Pacific time

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Our Client is a Global medical device Manufacturer.

We are looking for a Sr. Quality Engineer

We perform New Product Development of Surgical Medical Devices in this division, We are looking for an Engineer to perform & work mainly on Quality Tasks

• Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
• Driving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).
• Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).
• Create/update portions of design control documents including requirement specs and risk documents
• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
• Other duties assigned by Leadership

What you'll need (Required):

• Bachelor’s degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience
• CAD experience (Solidworks -or- Creo)
• Statistical based software (Minitab, JMP)
• Keyence, and Other Inspection Methods
• Data Analysis (Stat), 3D modeling
• Drawing Review and Inspection

Preferred Skills:

• Medical Device experience is strongly preferred
• Experience in test method development including Fixture development and Validation
• Basic understanding of statistical techniques
• Develop, update, and maintain technical content of risk management files
• Understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Good documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills
• Ability to interact professionally with all organizational levels & time management
• Ability to manage competing priorities in a fast-paced environment
• Ability to build productive internal/external working relationships