Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.
Review and approval of component qualifications for new products and those related to supplier changes.
Provide support and approval for all documentation required for the project deliverables (ex. generate new Inspection Procedures IP’s, Test Methods TM’s, Manufacturing Procedures MP’s, and obtain approvals).
Issue Change Request (CR) to upload documents into document control system and to support the on-going periodic review of documents and items as identified to maintain compliance.
Work with supplier in conducting investigations for incoming nonconforming investigation.
Following-up of Supplier Corrective Actions and reporting.
Issuance of supplier scorecards.
Completion of supplier performance assessments.
Issuance and follow up to completion of Supplier Quality Agreements.
Assist meetings and provide weekly reports when applicable.
Performs other related tasks as may be assigned by supervisor
Bachelor Degree in Engineering Required.
Three (3) or more years experience in the quality control field, in a pharmaceutical or medical device manufacturing facility.
Must be thoroughly knowledgeable on cGMP's, ISO 13485, and familiar with other regulatory requirements applicable to a medical device manufacturing operation.
Must be able to use problem solving techniques or root-cause analysis tools to solve product / process issues.
Must be able to read, interpret, and understand technical and non-technical documents, including but not limited to : contracts, product drawings, and product specifications.
Proficient in the use of Microsoft office and software for statistical analysis.
Must have strong verbal and written communication skills and must be able to successfully interface with technical and non-
technical personnel such as inspectors, designers, buyers, vendors, manufacturing personnel and management.
Must be fully bilingual (English / Spanish)
Desirable Qualifications :
ASQ CQE / CSSBB. Experience in Lean Manufacturing concepts is desirable.
Experience in Supplier Quality Management Systems is desirable
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.