Sr Quality Engineer - Design

ICU Medical; Tijuana; Presencial; MXN 1,281,000 - 1,649,000; Jornada completa

Descripción de la vacante

A leading medical device company in Tijuana, Mexico seeks an experienced Sr. Quality Engineer. The role involves ensuring product compliance with quality standards and regulations, utilizing quality tools, and coordinating with cross-functional teams. The ideal candidate has a Bachelor's degree in engineering, 7+ years of experience in the medical device industry, and strong bilingual communication skills. This position offers an opportunity to impact product quality significantly.

Formación

• 7+ years of experience in a similar role within the medical device industry.
• Hold ASQ CQE or CSQE certification or ability to obtain within one year.
• Strong knowledge of ISO 13485, ISO 14971, FDA regulations, and key medical device standards.
• Bilingual Spanish/English communication skills.

Responsabilidades

• Ensure compliance with quality standards and regulations.
• Utilize quality tools for process and product analysis.
• Coordinate product changes and work with cross-functional teams.
• Monitor product data to identify trends and risks.

Conocimientos

Quality assurance

Risk analysis

Regulatory compliance

Cross-functional teamwork

Statistical data analysis

Educación

Bachelor's degree in engineering

Descripción del empleo

The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Sr. Quality Engineer will provide quality assurance support for product realization/manufacturing teams. Reporting to the Quality Manager, this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.

Essential Duties & Responsibilities

• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
• Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
• Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
• Work with cross-functional teams to coordinate product changes.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
• Provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary.
• Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
• Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks.

• Bachelor’s degree in engineering from an accredited college or university is required.
• Minimum of 7+ years similar role in Medical Device Industry
• ASQ CQE or CSQE required or the ability to obtain within one year.
• Strong knowledge of medical device standards, including but not limited to:ISO 13485, ISO 14971, FDA, MDR and other key medical device regulations.
• Experience linking risk management to all elements of the QMS (Design Controls, CAPA, Complaints, Doc Control, etc)
• Excellent Bilingual Spanish/English verbal and written communication skills