Sr Quality Engineer - Design

ICU Medical Tijuana; Baja California; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Quality Engineer to ensure compliance with quality system requirements and applicable regulations. In this pivotal role, you will provide quality assurance support for product realization and manufacturing teams, ensuring that products are developed with the highest quality standards. You will work closely with cross-functional teams, participate in design reviews, and utilize various quality tools to continuously improve product quality. This position offers the opportunity to make a significant impact in the medical device industry while working in a collaborative environment focused on excellence.

Formación

• 7+ years in a similar role within the Medical Device Industry.
• Strong knowledge of ISO 13485, ISO 14971, and FDA regulations.

Responsabilidades

• Utilize quality tools to assure product quality and compliance.
• Coordinate product changes with cross-functional teams.

Conocimientos

Quality Assurance

Risk Analysis

Validation

Design Verification

Bilingual Spanish/English Communication

Educación

Bachelor’s degree in Engineering

Herramientas

CAPA data

Product and Process Controls

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