Quality Engineer (Lewisville, TX) - Paladin Consulting, Inc

Paladin Consulting is currently hiring a Quality Engineer to join our team working onsite at our client's office located in Lewisville, TX.

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Job Title: Quality Engineer
Work Location: Lewisville, TX
Duration: 18 month contract
Education/Experience Required: 3+ years Supervisory Experience: Experience working in a food, drug, or cosmetic consumer products manufacturing environment is preferred.

Job Description & Responsibilities :

• Contributes to global quality system to ensure R3 and contract manufacturers meet global quality requirements.
• Leads efforts with various groups (Marketing, R&D, Manufacturing, Supply Chain,
  etc.) to identify and resolve key technical issues related to products, packages, operations, and their combined interactions, both at the R3 site and at contract manufacturers.
• Provides Quality direction and technical oversight from cradle to grave for products produced in-house and at contract manufacturers.
• Responsible for quality engineering tasks for all processes for assigned products in pre and post-commercial distribution (for both site and contract manufacturing).
• Provides oversight and quality assessment of new products and processes to ensure quality product launches.
• Provides insight and direction on equipment design.
• This position improves the business by leading root cause analyses, implementing corrective and preventive actions, improving quality systems, managing quality awareness,
  and establishing/maintaining key liaisons with Operations, Commercialization, Site Engineering, R&D, Purchasing, Planning, Packaging Engineering, Brand, Contract Manufacturers, etc.
• Cross-functionally supports the Validation Master Plan alongside the validation engineers by assisting with cleaning, equipment, and process validation activities.
• Serves as technical expert for quality and quality compliance related issues (site and contract manufacturers) and works to resolve these issues and
  improve quality globally.
• Responsible for oversight of non-conformances and applicable tasks as assigned for site and contract manufacturers.

NEW PRODUCT & PROCESS DEVELOPMENT:

• 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.
• Participates in risk management activities to identify, design, and resolve risks and ensure mitigation in compliance with procedures.
• 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

NON-CONFORMANCE AND QUALITY METRICS MANAGEMENT:

• 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.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develops and recommends viable solutions in response to both immediate issue resolution and long-term systemic resolution and prevention of recurrence.

PROCESS OPTIMIZATION AND COMPLIANCE:

• Effectively communicates and reinforces the commitment to quality improvement efforts.
• Provides equipment and process capability reviews to support validation, compliance, and improvement activities for both company and contract manufacturing sites.
• Recommends changes to processes based upon findings and performs follow up to verify effectiveness.
• Optimizes manufacturing processes using statistical control and process designed experimentation to enhance manufacturing operations.
• Applies appropriate statistical techniques, quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies.
• Provides trending analysis on quality issues and performance metrics.
• Designs experiments to determine optimum operating settings for maximum fiscal efficiency and product quality.
• Troubleshoots process problems, recommends, and implement solutions.
• Manages additional special projects related to these objectives as required.
• Recommends policy and procedure changes as necessary and assures changes in process or material specifications are completed in accordance with change control procedures.
• Recommends modifications to existing specifications and tolerances as well as processing/ packaging parameters necessary to support cost effective and capable production and satisfied end consumers.
• Verifies that system changes at the supplier are implemented and monitors the systems over time to verify improvement.

ONGOING SUPPORT:

• Provides Quality engineering support to Site and CM Operations ensuring consistent application of quality techniques by: Interfaces with cross functional team members as needed (including but not limited to Quality Laboratories - Microbiology (QCM), Analytical (QCA), Quality Assurance (QA), R&D, Engineering, Regulatory Affairs, Package Engineering, Scheduling, Packaging, Processing and Central Weigh to design, plan, write protocols, execute, document results, and gain the required approvals for all validation activities.
• Plans and organizes validation execution activities, including scheduling validation runs, writing protocols, collecting and analyzing data, and documenting results.
• Independently plan, perform and/or coordinate validation projects to ensure timely completion.
• Develops and maintains effective internal and external relationships.
• Ensure that corporate Quality standards are met and consistently followed globally.
• Regularly assesses processes to determine if requirements are being met. Identifies gaps between required and current supplier capabilities and drives quality improvement plans and risk mitigation accordingly.

PROJECTS:

• Plans upcoming projects and develops recommendations for future projects to improve product quality.
• Utilizes knowledge, skills, and abilities effectively and trains others as necessary.
• Performs other duties as assigned by leadership

Skills & Qualifications :

• Experience: 3+ years
• Field of Experience: Experience working in a food, drug, or cosmetic consumer products manufacturing environment is preferred.
• Education: Bachelor/University Degree
• Education Focus: Bachelor's degree or higher in a related engineering or science field. Chemical Engineering or Chemistry is preferred.
• 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
• License/Certification Required/Preferred
• Certified Quality Engineer Preferred
• Decision Making: 5-Evaluates situations using multiple sources of information 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 self-motivated, pro-active and results oriented.
• 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.

For more information or to view other opportunities, visit us at www.paladininc.com.

Paladin Consulting is an EEOC employer.