INGENIERO DE CALIDAD SR

TACNA Services, Inc.; Tijuana; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

TACNA Services, Inc. in Tijuana seeks a Senior Quality Engineer to represent quality on projects and provide overall quality support to production and operations, including implementing the Quality Management System.

The role requires 5–10 years in a regulated medical device environment, fluency in English and Spanish, and strong knowledge of QMS standards and risk management. Work is on-site in Tijuana with a focus on continuous improvement.

Qualifications

• B.S. in Engineering or Science or equivalent technical field.
• 5–10 years in Medical Device Manufacturing or other regulated industry.
• Fluent in English and Spanish.
• Working knowledge of QMS standards like ISO 13485 and ISO 14971.
• Working knowledge of statistical techniques.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Represent quality on projects and support production and operations with QMS implementation.
• Participate in compliance with FDA QSRs, ISO 13485, ISO 14971.
• Review and execute process verifications and validations (IQ/OQ/PQ).
• Assist in creating and updating manufacturing procedures and work instructions.
• Support risk management activities related to manufacturing processes.
• Investigate non-conforming material and identify improvement opportunities.
• Assist supplier audits, manufacturing validation, and proposed changes.
• Perform internal audits and assist in hosting external audits.

Skills

Quality engineering

Regulated industry experience

Bilingual English/Spanish

Statistics knowledge

QMS ISO 13485 familiarity

ISO 14971 risk management

Lean/Kaizen

Documentation & communication

Education

B.S. in Engineering or Science

Tools

Excel

Databases

Word processing

Job description

Position Title: Senior Quality Engineer Reports To: Quality Leadership Department: RA/QA Summary of Position (Paragraph form): The Quality Engineer will be responsible for representing quality on projects, overall quality support to the production and operations organization including implementation of Vapotherm's Quality Management System.

Primary Responsibilities (Bulleted form):

• Participate in the execution of Quality functions in compliance with FDA QSRs, ISO 13485, ISO 14971, and other national and international quality requirements and standards.
• Assists in reviewing and executing process verifications and validations, including IQ/OQ/PQ protocol and report documentation.
• Cross-Functional team member assisting in preparation and updates of manufacturing procedure documentation.
• Support risk management activities related to manufacturing processes such as pFMEA.
• Review and assist in writing new procedures and work instructions or updating existing documents to drive process improvement.
• Evaluate and monitor manufacturing issues, and product concerns, and help investigate non-conforming material to determine opportunities for improving manufacturing and product performance.
• Support supplier related activities, such as supplier audits, manufacturing validation, and proposed changes.
• Performs internal audits and assists in hosting external audits.

Position Requirements - Education, Knowledge, Years of Experience, etc. (Bulleted form):

• B.S. in Engineering or Science, or equivalent technical field.
• 5-10 years in Medical Device Manufacturing or other regulated industry.
• Patient/Customer Focused Quality perspective.
• Working knowledge of QMS standards like ISO 13485 and familiarity with Risk management standards like ISO 14971
• Working knowledge of statistical techniques.
• Working knowledge in spreadsheets, databases, and word processing software programs.
• Strong attention to detail.
• Highly organized.
• Fluent in English and Spanish
• Effective written and oral communication skills.
• Ability to work as a team or independently in a changing, fast-paced, deadline-driven environment; must be driven and able to accept new challenges and continually strive for improvement in the support of effective therapy delivery to the patient and a delighted user experience.
• Employ an engaged, collaborative mindset with teammates within the RA/QA department, as well as during frequent project interface with interdepartmental (Manufacturing Engineering, Production) colleagues.
• Must have experience with and demonstrable competencies in Lean Manufacturing (e.g. Toyota Production System). Including leading Kaizens/Continuous Improvement techniques, Standard Work, Single Piece Flow, Kan Ban, 5S, SMED, Value Stream Mapping, and Poka Yoke

Vacantes Abiertas 1 Turno L-J:7:00-17:00, V:7:00-15:00

City Tijuana

Idiomas English (80 %)

Visa

Sentri