QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

　　Responsibilities:

　　Leader within the quality team with respect to development of product specifications, data collection systems, line audit creation, developing answers to internal and external complaints, and creation of cross functional SOPs.

　　Comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function. 

　　Assures adequate internal quality standards are in place.

　　Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.

　　Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.

　　Develops experiments by applying full and fractional factorial techniques.

　　Develops sampling plans by applying attribute, variable, AQL, and sequential sampling methods.

　　Maintains statistical process controls by applying charts for distributions and individual-medial/range for multi-stream processes.

　　Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.

　　Prepares reports by collecting, analyzing, and summarizing data; making recommendations.

　　Designs and implements quality assurance systems consistent with industry standards that increase quality levels.

　　Serves as primary trainer for all quality programs and initiatives.

　　Oversees the tracking and completion of corrective actions.

　　Qualifications:

　　Bachelor’s Degree in Engineering,Science, Statistics or Quality-Related or equivalent work experience

　　5 years of experience in Quality Assurance

　　Supervisory experience preferred

　　CQE & Six Sigma Certifications preferred

　　Proficient with Microsoft Office

　　Investigation of customers complaints, reports and follow-up actions.

　　Able to do documentation of complaints, CAPA, internal audit and all related documents into the Entropy system.

　　Development of validation protocols, execution, documentation and closure.

　　CGMP annual training.

　　Procedure, policy revision, translation and implementation.

　　Participate in internal and external audit.

　　Response to customer audits, CAPA implementation and closure.

　　Ensures that change controls/Corrective Actions /Customer Complaints are managed and responded to in a timely fashion.

　　Evaluated systems trending (Complaints, CAPA, Internal deviations, etc.).

　　Able to Work with FAI, PPAP and any other customer requirements.

　　Compensations:

　　15 days of annual's vacations

　　12 sick days per year

　　Medical plan, employer contribution 80%

　　Dental plan, employer contribution 80%

　　Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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