Category: Manufacturing & Production

Employment Type: Contract

Reference: BH-379767

Manufacturing Quality Engineer 2 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 in an engineering or scientific discipline with a minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing is desirable.


Shift: Monday - Friday, 8 am to 4 pm/ 9 am to 5 pm.

Key Responsibilities

• This position is responsible for manufacturing and product Quality activities including direct interaction with the Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. This role is within Mfg/Ops Quality organization and is accountable for driving change, establishing sustainable processes, improving products, providing actionable process and product data, supporting risk management activities and development of process/product validation strategies, and sharing best practices. This position works on problems of limited scope, follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained, builds stable working relationships internally to effectively coordinate activities, completes assigned actions on time according to plan, proactively communicates challenges in advance of due date(s), requires strong communication, provides supporting data to project lead on risk in area of responsibility, delivers results, and applies quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD) where appropriate.

• A minimum of 2 to 4 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing is desirable.
• Experience with quality and process improvement methodologies and tools desired.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands.
• Ability to execute strategy, approach, methods and actions on new assignments.
• Is considered a subject matter expert for assessing and resolving complex quality issues.
• Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.
• Experience with data mining, trend analysis, and statistical analysis.
• Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
• Experience with enterprise Quality System tools (e.g., electronic CAPA/NC, Change Management systems).
• Background in oligonucleotide synthesis and surface activation chemistry a plus.

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