Quality Engineer II

MiniMed•Juncos, PR

9d•Onsite

About The Position

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. Every product we deliver carries a patient's trust. As a Quality Engineer II, you are the frontline defender of that promise — ensuring every process, every standard, and every decision protects the people who depend on our life-changing diabetes technology. Responsibilities may include the following and other duties may be assigned. 3rd Shift Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Requirements

Requires Engineering Bachelor Degree
Requires minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Nice To Haves

Minimum 2 Years of experience in Quality Engineering for manufacturing operations in the Medical Device industry.
Knowledge in Nonconforming Material Investigations and CAPA.
Knowledge in bounding exercises and Manufacturing Executing Systems (MES) management.
Able to write and Speak in English and Spanish.
Software knowledge (Minitab).
Automation Systems knowledge.
Validation Knowledge (IQ, OQ, PD (PDR), PQ).

Responsibilities

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.