Supplier Quality Engineer

Location: Humacao, PR, Puerto Rico
Date Posted: 09-06-2018
SUPPLIER QUALITY ENGINEER

Description

The successful candidate must have field Packaging experience, in regulated environment industries such as solid dosages industry, medical device, pharmaceutical and/or biopharmaceutical. The Supplier Quality Engineer will provide support to the packaging engineering team and will be responsible for supplier qualification and packaging validations, also support validation activities coordination and execution.

Duties and Responsibilities
  • Supplier Material Qualification.
  • Generation and completion  DOE, OQ, PQ, traceability matrix and  among others.
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field.
  • Be able to implement Validation standards daily Implements policies and procedures to validate/qualify packaging material and processes in accordance with regulatory requirements and company manufacturing standards.
  • Generates, executes, reviews, and complete regulatory documentation required to develop packaging material specifications.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
  • Participation on the project management to assure project deliverables are done in a timely manner.
 
Skills and Specifications
  • Experience with packaging validations
  • Supplier Qualification
  • Good problem-solving skills
  • Sense of urgency
  • Organized
  • Detail oriented
  • Availability to work overtime including weekend depending on project requirements
  • Capable of working with minimum or no supervision
  • Strong interpersonal skills
  • Teamwork oriented
  • Fully Bilingual (English and Spanish) - REQUIRED, oral and writing communication
 
Years of Experience
2 to 5 years of experience related.

Education
Minimum bachelor’s degree in mechanical, Electrical and Industrial Engineering or related field.



Ultimate Solutions Corp is an Equal Opportunity Employer.
 
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