Category: Manufacturing & Production

Employment Type: Contract

Reference: BH-379595

Manufacturing Quality Engineer needed for a contract opportunity with Yoh Scientific's client located in San Diego, CA.

This position will be for a major biotech company and requires someone with a bachelor's degree and minimum 2 years of experience in a manufacturing support or R&D laboratory setting.

Shift: This is a hybrid role and has an assigned desk. The contractor will be required to be on site at least 3 days per week. However, it doesn't need to be from 8AM to 5PM and can be any day of the week unless otherwise requested by the manager for a specific meeting or event.

There are times you would work in the evening (after 5PM) working with our Singapore counterparts, or if an escalation arises, but it is uncommon.

Key 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

• 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.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs