As a medical device company, we help people in a truly tangible way.
We are one of the most modern electronics factories, which gives us the opportunity to develop and build a career working with the latest technologies.
About Us
The knowledge and skills you'll gain here are unique, and you'll find new challenges and endless opportunities along the way.
Our facility is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies, and complete devices up to and including Class III medical devices.
Sanmina's core specialization is manufacturing automation.
Services We Offer
We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping, and repair.
We create a state-of-the-art environment for manufacturing medical and other high-quality devices.
The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.
Quality Engineer
Objectives of Position
The primary objective is to ensure customer satisfaction by monitoring, controlling, and improving all related customer processes.
The principal customer interface for Quality metrics and improvement initiatives.
Responsibilities
* Management of closed-loop customer complaints and improvement processes.
* Generation and review of Quality Metrics System.
* Overall responsibility for DMR/DHR and Technical Files.
* Data collection, analyzing, and reporting.
* Pareto and trend analysis.
* Initiate and drive Continuous Improvement programs.
* NPI Approval including First Article Inspections and Reporting.
* CAPA, NCM, and RMA analysis and Improvement.
* QSR Validation protocols and report (IQ, OQ & PQ).
* Conducting Audits to ensure conformance and effectiveness of the Quality System.
Measurements
* Yields at Key Process Steps
* Customer Satisfaction Index, (CCN, CSO etc)
* Customer Return % and Cost (RMA)
* Scrap % Outgoing Inspection DPM & Customer Incoming Quality Levels
Personnel Specifications
Essential
* University Degree in Science or Engineering.
* At least 2years of Quality Assurance experience in a similar Quality Engineering role.
* Sound understanding and utilization of Problem Solving Techniques.
* Proficient in the use of Microsoft Word, PowerPoint, and Excel.
* Good Communications and influencing skills.
* Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
* Ability to write standard operating procedures, training documents, and regulatory responses.
Desirable
* Experience in working within a Medical Device Manufacturing Environment or similar.
* Six sigma Green or Black Belt Certified Experience in New Product Introduction Processes