Sr. Supplier Quality Engineer

Posted Yesterday
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Juncos, PRI
In-Office
Senior level
Pharmaceutical
The Role
The Senior Supplier Quality Engineer will oversee supplier quality assurance, manage approvals, audits, and ensure compliance with manufacturing and quality standards in the medical devices industry.
Summary Generated by Built In

For Supplier Quality services in the Manufacturing/Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's degree in Engineering and a minimum of four (4) years of relevant experience, or an advanced degree with a minimum of two (2) years of relevant experience within the medical devices industry. 
  • Bilingual (English & Spanish).
  • Work Type: Remote 
  • Shift: Administrative and according to business needs
  • Experience in:
    • Distribution Centers and 3PL's suppliers 
    • Leading Projects
    • SAP, Agile and Trackwise desired.

The Personality Part:    

  • If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Support the Supplier and Distribution Quality organization to identify and establish the Approved Supplier List (ASL) for Distributors and 3PL's, negotiate Quality Agreements, monitor the performance, develop and execute the audit schedule, as well as supporting on validation and qualification activities with these suppliers. 
  • Ensures that suppliers deliver quality parts, materials, and services. 
  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. 
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur through the Supplier CAPA process. 
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. 
  • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. 
  • May have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering, Post-Market Supplier Quality and Distribution Teams, to deliver quality parts, materials, and services, prevent defects, to provide customers with the highest quality and reliable products. 
  • Collaborates with Distribution in the selection of new Distributors and 3PLs. 
  • Define Receiving Inspection requirements as required and associated test method validation.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?

Skills Required

  • Bachelor's degree in Engineering
  • Minimum of four years of relevant experience in the medical devices industry
  • Bilingual in English and Spanish
  • Experience with Distribution Centers and 3PL's
  • Experience leading projects
  • Experience in SAP, Agile and Trackwise
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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