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Manufacturing Quality Engineer

1 month ago

Fremont, United States TekWissen LLC Full time
Job DescriptionJob Description

Overview

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

Position: Quality Engineer III
Location: Fremont, CA, 94538
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 8.00 am to 5.00pm

Job Description

  • Design, implement and review test plans and protocols to ensure that medical device/equipment products meet all quality standards.
  • Oversee product quality throughout the entire product design realization process.
  • Work closely with research and development to support new product development and improve product design.
  • Investigate non-conformances and suggest changes as necessary.
  • Work under general supervision with latitude for independent judgment.
  • Required to consult with internal stakeholders on certain projects as required.

Responsibilities:

  • Lead, Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, IVDR and QSR regulations.
  • Drive and ensure proper design controls are appropriate during design reviews.
  • Manage input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates.
  • Manages the pre- & post-production Design Assurance/Quality Engineering activities as they relate to product lifecycle development
  • Review and approval of validation protocols and reports. Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed.
  • Verify configuration management and Risk Analysis records are properly addressed, accurate, and maintained.
  • Review test protocols and final reports for completeness and accuracy.
  • Ensure design changes are processed in accordance with current change-control requirements.
  • Manage and complete assigned tasks on schedule, and identify and propose resolution for issues that may affect the timeline for remediation activities.
  • Provide quality engineering support for investigations as required.
  • Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.
  • Lead and support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.

Required Qualifications:

  • Bachelor's degree with a minimum of 7 years of experience in medical device quality assurance.
  • Proficiency in all MS Office products
  • Quality engineering certification (ASQ CQE or CQA) desired
  • Knowledge of lean six sigma manufacturing processes
  • Additional professional training in lean processes such as green belt training a plus
  • Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company
  • Demonstrated and impactful experience in product and process validation, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC).
  • Ability to interpret trends and data, translating the information into actions, outcomes and improvements
  • Excellent documentation skills, with a solid process orientation and effective attention to detail
  • Strong verbal and written communication skills
  • Self-starter and independent critical thinker, with the aptitude to work autonomously

TekWissen Group is an equal opportunity employer supporting workforce diversity.