Senior Quality Engineer – Med Device QA & Compliance

Medtronic

Humacao (PR)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Medtronic in the United States is seeking a Sr. Quality Engineer to support QA activities in a regulated manufacturing environment, ensuring products meet quality, regulatory, and business requirements.

The ideal candidate has a bachelor’s in engineering and 4+ years of relevant experience (or higher degrees) with strong problem-solving, quality systems knowledge, and hands-on CAPA, investigations, and documentation experience.

Qualifications

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
Bachelor’s degree in engineering is required; 4+ years of engineering, quality, or manufacturing experience preferred.

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 cost and responsibility for products or materials that do not meet standards.
Ensures corrective measures meet reliability standards and documentation is compliant with requirements.
May specialize in design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.