Senior Design Quality Engineer
hace 1 día
The Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. They are responsible for accurate generation and evaluation of Design History File documentation and Quality System compliance. Essential Job Functions and Responsibilities Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations Assist with efforts to resolve advanced technical and Quality-related problems Contribute to New Product Introduction Projects as a core team member and communicate activities to the team members of Quality Support transfer activities by developing and executing the transfer validation strategy Support the product development teams in the adoption and use of best practices, Quality tools-Design Control methodologies Leads root cause investigation using Lean Principles and Tools Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and addressed Monitor and develop reliability improvements to existing & new designs Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence Support supplier development and continuous improvements; monitoring supplier performance, KPI’s, implementing corrections, and audits Support verifications for cost, quality, and capacity initiatives. Report on achievement of targets and identify any actions required Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485 Evaluate quality data and prepare reports to monitor trends Generate and approve Engineering & Development Change Orders Support internal/external audits Required Qualifications Bachelor’s degree in Engineering or Science (or similar) is required.
Master’s degree is preferred. Minimum of 7 years of hands‑on experience in the Quality Engineering discipline. Prior experiences in the medical device field is required; preferably experience with Capital Equipment and single use medical devices. Knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Must be able to communicate fluently in both written and spoken English Desired Qualifications Ability to work effectively in a fast paced and dynamic environment. A self-starter, motivated and able to positively motivate others. Focused, target driven with a positive, can-do attitude. Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system.
Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers. Strong written and verbal communication skills. Certified Quality Engineer a plus. Lead Auditor certification a plus.
Lean Certification a plus.
Experience
with statistical analysis software a plus #J-18808-Ljbffr
-
Senior Quality Engineer, Design
hace 2 días
Tijuana, México ICU Medical A tiempo completoDirect message the job poster from ICU MedicalHuman Resources Professional, SHRM-CP, HRBPPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. The Sr. Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and...
-
Senior Design Quality Engineer
hace 14 horas
Tijuana, México Outset Medical, Inc. A tiempo completoA medical device manufacturer in Tijuana seeks a Senior Design Quality Engineer to support quality activities related to design and reliability. The role involves technical reliability support, leading root cause investigations, and ensuring compliance with FDA and ISO standards. Candidates must have a Bachelor's in Engineering or Science, with at least 7...
-
Senior Design Quality Engineer
hace 6 horas
Tijuana, México Outset Medical, Inc. A tiempo completoA medical device manufacturer in Tijuana seeks a Senior Design Quality Engineer to support quality activities related to design and reliability. The role involves technical reliability support, leading root cause investigations, and ensuring compliance with FDA and ISO standards. Candidates must have a Bachelor's in Engineering or Science, with at least 7...
-
Tijuana, México Outset Medical Mexico A tiempo completoA leading medical device company in Tijuana seeks a Senior Design Quality Engineer to ensure compliance with design control requirements. This role entails providing support for product development, contributing to new product introduction projects, and conducting risk analyses. Candidates should possess a Bachelor's degree in Engineering or Science, with 7+...
-
Tijuana, México Outset Medical Mexico A tiempo completoA leading medical device company in Tijuana seeks a Senior Design Quality Engineer to ensure compliance with design control requirements. This role entails providing support for product development, contributing to new product introduction projects, and conducting risk analyses. Candidates should possess a Bachelor's degree in Engineering or Science, with 7+...
-
Senior Design Quality Engineer
hace 14 horas
Tijuana, México Outset Medical, Inc. A tiempo completoAs a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability. The Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. They...
-
Senior Design Quality Engineer
hace 1 día
Tijuana, México Outset Medical Mexico A tiempo completoThe Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. They are responsible for accurate generation and evaluation of Design History File documentation and Quality System compliance. Essential Job...
-
Tijuana, México Outset Medical A tiempo completoA pioneering medical device company in Tijuana is seeking a Senior Design Quality Engineer to support quality activities related to design and development. The role involves ensuring compliance to quality requirements and fostering best practices in product development. Responsibilities include providing technical support, leading investigations, and...
-
Senior Quality Engineer, Design
hace 1 semana
Tijuana, Baja California, México ICU Medical A tiempo completoPosition SummaryProvide quality support for ICU Medical Product and Development and design changes. 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...
-
Tijuana, México Outset Medical, Inc. A tiempo completoA leading medical device company in Tijuana is looking for a Senior Design Quality Engineer to enhance quality compliance and support design transfer to manufacturing. The role requires a minimum of 7 years in quality engineering, experience in medical devices, and fluency in English. Responsibilities include providing reliability support, leading root cause...
