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ECHO Consulting Group

Validation and regulatory documentation for pharma

Supplier Quality Engineer 1

Quality EngineeringConfirmed live in the last 24 hours
ContractPuerto RicoNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering is required.
  • Knowledge of good manufacturing practices (GMPs) is preferred.
  • Experience with validation of equipment and processes is preferred.
  • Experience with risk analysis is preferred.
  • The role is an entry-level individual-contributor position working with close supervision.

Responsibilities

  • Ensure that suppliers deliver quality parts, materials, and services.
  • Qualify suppliers according to company standards and potentially administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur.
  • Develop and prioritize an auditing schedule to ensure designated suppliers are audited regularly and meet good manufacturing practices (GMP) and quality standards.
  • Evaluate suppliers' internal functions to assess overall performance and provide feedback on their operations.
  • For some individuals, provide Pre-Market Quality Engineering support to New Product Development (NPD), partnering with Component Engineering and Post-Market Supplier Quality teams to deliver quality parts, materials, and services, prevent defects, and support high-quality, reliable products.
  • Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle for newly qualified parts, implementing strategies to drive product quality and continuous improvement, and ensure purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
  • Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, coordinate the Approved Supplier List, deploy Supplier Owned Quality, and establish Control Plans for new products.
  • Define Receiving Inspection requirements as needed and validate associated test methods for internal Medtronic test methods.

Desired Qualifications

  • Knowledge of good manufacturing practices (GMPs).
  • Experience with validation of equipment and processes.
  • Experience with risk analysis.

About the Company

ECHO Consulting Group

Validation and regulatory documentation for pharma

Echo Consulting Group provides specialized validation and regulatory documentation services for the healthcare, pharmaceutical, and biotechnology industries. Its offerings include process, cleaning, equipment, and computer systems validation, paired with regulatory compliance work and audit-ready documentation that meets cGMP and FDA requirements. The firm differentiates itself through long-standing expertise since 2002 and its integration into PharmaLex, which expands access to global resources while keeping its technical focus. Its goal is to help life-sciences organizations achieve regulatory success and efficient validation by delivering reliable documentation and support for validation efforts.

Company size
Not listed
Company stage
Not listed
Total funding
Not listed
Headquarters
Caguas, Puerto Rico
Founded
2002

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