Sr Quality Engineer

Job Description

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.

Full-time