Supplier Quality Engineer I - 109
Flexible & Integrated Technical Services, LLC • Villalba, Puerto Rico
Role & seniority
- Engineer (entry to early-mid level) in Manufacturing, with focus on Supplier Quality in Medical Devices.
Stack/tools
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Engineering fundamentals; supplier quality processes; auditing; process validation; root cause analysis; basic computer software proficiency.
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Bilingual: Spanish and English
Top 3 responsibilities
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Ensure suppliers deliver quality parts, materials, and services; qualify suppliers and oversee cost-effective Certified Supplier Program in receiving inspection.
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Monitor parts from acquisition through manufacturing; communicate and resolve supplier-related problems; develop/audit supplier schedules for regulatory compliance.
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Provide Pre-Market Quality Engineering support to New Product Development (NPD) with Component Engineering; support Post-Market Quality Teams to prevent defects; guide supplier quality throughout the NPD lifecycle.
Must-have skills
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Bachelor’s degree in Engineering; 1 year of experience in Medical Devices.
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Bilingual: Spanish and English.
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Strong writing and communication skills.
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Computer proficiency; problem-solving techniques; root cause analysis; process validation; familiarity with computer software.
Nice-to-haves
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Experience administering or participating in Certified Supplier Programs.
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Experience with Pre-Market and Post-Market Quality activities across NPD lifecycles.
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Knowledge of industry standards and regulatory requirements relevant to medical devices.
Location & work type
Location: not specif
Full Description
For Engineer services in the Manufacturing area.
WHAT MAKES YOU A FIT
The Technical Part
- Bachelor’s Degree in Engineering and one (1) year of experience within the Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Writing and communication skills
Shift: 1st and according to business needs.
Experience in
- Computer proficiency
- Problem-Solving Techniques
- Root Cause Analysis
- Process Validation and Computer Software.
The Personality Part
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure compliance with regulations. Evaluates suppliers' internal functions to assess their overall performance and provides feedback on their operation. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties. Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering. Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, and prevent defects. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle for newly qualified suppliers. Improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards.
WHO WE ARE
- We are a Service Provider company different from the rest. We pride ourselves on 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 Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS!
- Are you the Next Piece?
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