5 часов назад
Quality Engineer I (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Engineer I (Medtech): Supporting product, process, equipment, and manufacturing changes in medical technology with an accent on quality standards, inspection methods, validation, and regulatory documentation. Focus on assessing risk, performing statistical analysis, implementing corrective measures, and ensuring compliant execution across engineering and manufacturing functions.
Location: Juncos, Puerto Rico, United States of America; onsite
Company
develops healthcare technologies intended to alleviate pain, restore health, and extend life.
What you will do
- Support engineering activities related to product, process, equipment, materials, components, tooling, and manufacturing-process changes.
- Develop, modify, apply, and maintain quality standards and processing protocols.
- Collaborate with engineering, manufacturing, quality, supply chain, regulatory, R&D, and laboratory partners.
- Design or specify inspection and testing mechanisms and conduct quality assurance tests.
- Perform statistical analysis to evaluate nonconforming products or materials.
- Ensure corrective actions, validation activities, and documentation meet reliability and compliance requirements.
Requirements
- Bachelor's degree in Engineering.
- Relevant experience is not required.
- Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
- U.S. work authorization sponsorship is not available for this below-Principal-level role.
- For bachelor's degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice to have
- Problem-solving experience.
- Experience with regulatory agencies.
- Green Belt certification.
- Knowledge of Kepner-Tregoe and DMAIC problem-solving techniques.
- Knowledge of statistical techniques and risk-management standards.
Culture & Benefits
- Mission-driven work focused on healthcare technology and patient outcomes.
- Competitive compensation and a flexible benefits package.
- Short-term incentive eligibility through the Incentive Plan.
- Reasonable accommodations are available for qualified individuals with disabilities.
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