Supplier Quality Engineer (SQE)
Validation & Engineering Group, Inc
Humacao, Puerto Rico
hace 33 días

Company Description

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.

Job Description

  • 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
  • Qualifications

  • 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.
  • ASQ CQA
  • Experience in Supplier Quality Management Systems is desirable
  • Additional Information

    Positions available for Puerto Rico.

    Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

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