Staff Quality Engineer

Sistemas Médicos Alaris (BD) planta EMI; Tijuana; Presencial; USD 30,000 - 50,000; Jornada completa

Descripción de la vacante

A leading company in the medical device industry is seeking a Quality Engineer to develop and implement reliability analysis and validation methods. The role involves providing quality leadership to product development teams and ensuring compliance with FDA and ISO regulations. Candidates should have a Bachelor's degree in engineering, extensive experience in quality assurance, and strong leadership skills.

Formación

• 10+ years of experience in quality assurance within a regulated environment.
• 6+ years of experience in the medical device industry.
• Quality certification (e.g., CQE) preferred.

Responsabilidades

• Develop and implement reliability analysis and validation methods.
• Provide quality leadership to new product development teams.
• Drive product risk management activities.

Conocimientos

Problem identification

Problem-solving

Communication

Leadership

Educación

Bachelor’s Degree in Mechanical, Electrical, Industrial, Reliability Engineering

Descripción del empleo

Accountabilities:

1. Develop and implement reliability analysis, design, validation, and assessment methods to support successful new product introductions and/or sustaining product changes.
2. Provide quality leadership to new product development teams in areas such as design control, design verification and validation, design transfer, process validation, risk management, and specification development.
3. Drive product risk management activities and ensure the quality and completeness of project design history files, validation packages, and change orders.
4. Provide ongoing quality engineering support throughout the product lifecycle. Support development, engineering, and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs, strategies, and requirements. Ensure product development and validation programs meet FDA and ISO requirements when applicable.
5. Collaborate with Engineering and R&D to develop reliability testing and modeling methods specific to products and systems, including HALT, Shock and Vibration, Weibull, MTBF, and others as required.
6. Set reliability goals for products and their subsystems in the field and measure progress. Maintain a knowledge base of lessons learned to enable continuous improvement.
7. Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting, utilizing data analysis techniques to meet accepted reliability standards.
8. Write detailed risk assessments, update process hazard analyses, and present analyses to the Risk Management Board.
9. Trend, analyze, and report on quality data to improve products and processes; develop recommendations based on data analysis.
10. Provide management with status updates on responsibilities and goals, and escalate issues timely.
11. Qualifications:

• Bachelor’s Degree in Mechanical, Electrical, Industrial, Reliability Engineering, or a related field.
• Minimum 10+ years of experience in quality assurance within a regulated environment.
• Minimum 6+ years of experience in the medical device industry.
• Quality certification (e.g., CQE) preferred.
• Knowledge of medical device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971).
• Results-oriented with strong written and oral communication skills to lead cross-functional teams.
• Ability to effectively lead and influence cross-functional teams.
• Strong problem identification and problem-solving abilities.