Quality Engineer

3 weeks ago


san diego, United States inSync Staffing Full time

Quality Engineer 1

$30.00-$37.25/hr

8am-5pm Mon-Fri

Onsite: San Diego, CA - Hybrid - onsite 3 days per week

4 month+ assignment


JOB DESCRIPTION


Responsibilities:

  • Develop global governance of quality system controls in SAP Establish and/or improve system controls in SAP for release of raw material, component and final product
  • Develop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standards
  • Utilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceeded
  • Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
  • Establish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignment
  • Engage SMEs to Validate (i.e. vet with SMEs, stakeholders, and key site Quality personnel) all Quality department ERP requirements before configuration Host design reviews, specifically addressing key
  • Quality decisions, processes, and ERP (and related) configurations
  • Advises and consults on QMS project/quality plans, risk assessments and remediation plans Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues


Requirements:

  • 0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
  • Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD)
  • Knowledge and experience with instituting quality controls in an ERP system, SAP preferred Highly effective communication, facilitation and negotiation skills
  • Adaptable to fast-paced, dynamic work environment with shifting demands
  • Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.
  • Changes to individual responsibilities may occur due to business needs.


Benefits:(employee contribution)

 Health insurance

 Health savings account

 Dental insurance

 Vision insurance

 Flexible spending accounts

 Life insurance

 Retirement plan



All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


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