Laboratory Quality Engineer

2 months ago

Lewisville, United States Yoh, A Day & Zimmermann Company Full time

Laboratory Quality Engineer

Lewisville, TX (Onsite)

18+ month contract


Responsibilities:

Under general direction, provides quality technical input to new product design reviews for assigned products (in-house and contract manufacturing). Uses quality tools (i.e. FMEA, etc.) to systematically assess product technical risks and recommend mitigation actions.

Collaborates with senior quality partners and various Marketing, R&D, Manufacturing and Supply Chain groups to identify and resolve key technical issues identified in development related to products, packages, operations, and their combined interactions.

Analyzes engineering specifications, design changes and other data to plan support activities from conceptual stage through the production launch of the product at contract manufacturers.

Support of the New Product Development process includes completing assigned tasks (historical reviews, line trials, technical assessments, validation activities, etc.) and attending and providing quality technical input at team meetings throughout the project lifecycle.

Collaborates with cross functional Supply Chain team as assigned to ensure successful project closure. Review and support, as needed, supplier capability audits and provide support for startup and issue resolution.

Leads nonconformance/quality metrics investigations, root cause analyses and resulting process improvements for the assigned areas/products at R3 and contract manufacturers.

Responsible for technical investigation and corrective action recommendations for quality problems identified, both in site production and contact manufacturing and recommends and applies appropriate control plans to achieve issue containment.

Ensures the organization performs in depth and documented root cause analyses and then monitors the effectiveness of the identified actions.

Partners with cross-functional team members (including but not limited to Quality, R&D, Manufacturing Operations, Purchasing, Engineering, and Legal) to request input to aid in investigations, root cause analysis, and development and implementation of corrective action plans.

Responsible for Process Optimization and Compliance; as well as Ongoing Support for Quality Laboratories


Requirements

Must possess strong technical skills.

Experience with Good Manufacturing Practices and certification by ASQ as a CQE or CQT is preferred.

A good understanding of audit protocol, statistics, inspection procedures, Lean Manufacturing, Lean Six Sigma and FDA GMP regulations is necessary to make sound decisions based on available information.

Must possess excellent written and oral communication skills and the ability to facilitate communications between various groups to achieve quality objectives.

Must be diplomatic and able to work effectively with cross-functional work groups including suppliers, customers and peers, both verbally and in writing. Must be able to forge coalitions.

Must have proven track record of driving continuous quality improvement in a manufacturing environment and have thirst for continuously seeking new knowledge and application opportunities.

Must have excellent project management skills in order to perform and prioritize a wide variety of activities simultaneously.

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