Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr. Quality Engineer

Qualifications:

• Must have fundamental knowledge/experience in statistics, SPC, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.
• Knowledge in DOE, Six Sigma, and product transfer.
• Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP and, auditing principals.
• Prior experience auditing FDA regulations.
• Bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines.
• Credentials of a Certified Quality Engineer are a plus.
• Able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task.
• This is an onsite role.
• Bachelor’s degree in Engineering (Industrial, or CQE preferred), advanced degree or process towards advanced degree is a plus.
• A minimum of (7) seven years’ experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.

Responsibilities:

• Review plant defect reports, customer complaints, failure investigations and audit findings to assess manufacturing related issues that may impact quality and recommend courses of corrective action.
• Conduct manufacturing non conformances investigations, customer complaints, CAPA, failure investigations and audit findings.
• Escalate manufacturing related issues that may impact quality and recommend courses of corrective action.
• Participate in regulatory agencies audits.
• Assist in the investigation of product non conformances and the gathering of information during regulatory inspections and field actions when required.
• Approve or review product investigations reports.
• Perform and report line defects trend analysis, cost of quality, and period quality summaries.
• Participate in new product or technology transfers to assess the impact they may have on the quality and reliability of the product – assist in process validation protocol.
• Follow-upon commitments to FDA and ISO observations for manufacturing related issues and report trends.
• Perform quality system audits to determine compliance to FDA, ISO, and internal quality systems regulations and perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.
• Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.
• Be an active member in facility continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement.
• Provide leadership and guidance to a team of hourly or salary associates, including assigning tasks, setting clear goals, and monitoring performance, as required.
• Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge.
• Develop individual team members through coaching and mentoring.