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ID #15621409
State California
City Alisoviejo
Job type Contract
Salary USD $50 - $55 per hour 50 - 55 per hour
Source Real Staffing
Showed 2021-06-19
Date 2021-06-19
Deadline 2021-08-18
Category Et cetera
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Quality Engineer III

California, Alisoviejo, 92656 Alisoviejo USA

Vacancy expired!

OVERVIEW:

Set up and manage the Good Manufacturing Practices for the production of Company devices and accessories. Support the development of Company devices and accessories. Develop, implement and maintain policies and procedures to ensure compliance with Quality System Regulations (QSR's) for medical devices. Establish documentation control and approval work flows to support manufacturing and testing for processes, test methods, test results, batch records, etc. for manufacturing. Establish material control procedures and policies for material flow in and out of the manufacturing space. Work with Product Development, Manufacturing, and Quality Control departments to ensure product quality and regulatory compliance. Perform supplier selection, qualification, maintenance, and audit activities in support of product development and manufacturing. Develop inspection techniques for materials and assemblies for incoming, inprocess, and final inspection. Support product audits and audits performed by regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Lead the review of all material review board dispositions within functional area
  • Read, comprehend and follow documents outlining all procedures related to the light adjustable lens
  • Establish and maintain document control practices for the manufacturing area including batch records, data systems, and material release
  • Create, review, and maintain risk management files within functional area
  • Review test results and release material for use
  • Establish and maintain material control practices for the production area
  • Perform audits of manufacturing practices to confirm operations to established processes
  • Maintain and update equipment development, validation, and installation process
  • Control materials for use in manufacturing and non-conforming materials
  • Work with suppliers to ensure quality system requirements are understood and successfully met
  • Maintain compliance to latest standards for optics, electronics, mechanics, and software as required
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledgeable of 21 CFR 820, 21 CFR 807, 21 CFR 806, and 21 CFR Part 11
  • Knowledgeable of ISO 13485 and 14971
  • Knowledgeable of IEC 60601-1
  • Knowledgeable of requirements for medical devices in US, EU, Mexico, Canada, Australia, and other markets
  • Able to perform product failure analysis
  • Able to perform basic statistical analysis
  • Strong interpersonal skills, well-established computer, communication and presentation skills
  • Able to run complaints, CAPA, training, non-conformances, change control, engineering change requests, and other quality systems
EDUCATION, EXPERIENCE, and TRAINING:

  • BS degree in an engineering or science discipline or combined education and experience.
  • Minimum of 5 years of experience performing quality assurance/regulatory affairs and developing processes in a manufacturing and/or product development environment preferably in the medical device industry.
Training to be completed per the training plan for this position as maintained in the document control system.

Benefits:

  • Health insurance
  • Casual Dress code
  • 401k match

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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Vacancy expired!

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