Quality Engineer

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.