Flexible & Integrated Technical Services, LLC
Supplier Quality Engineer 1 -122
Pharmaceutical - Ponce, PR, Puerto Rico - Contracted
For Quality Assurance services in the Manufacturing - Incoming Inspection area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s degree in Engineering and a minimum of two (2) years of related experience within the Pharmaceutical or Medical Device industry.
- Bilingual: (Spanish & English)
- Experience with:
- Statistics, sampling plans, and incoming inspection
- GD&T and technical drawing interpretation
- Inspection method evaluation and change control processes
Our Next Piece is someone who thrives on precision and problem-solving. You’re analytical, detail-oriented, and driven by a passion for quality. You tackle challenges with patience and purpose, making thoughtful improvements and keeping compliance front and center. You communicate clearly within your team and are committed to growing your skills. 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 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.
- 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 and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
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?
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