Quality Engineer

hace 2 semanas

Tijuana, México Stryker A tiempo completo
Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Who we want:

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
  • Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

The Quality Engineer is specifically assigned to establish, enhance, and maintain the quality system within the framework of designated projects. The primary goal of this role is to ensure the ongoing maintenance of the quality system to ensure the delivery of products that meet customer specifications and adhere to relevant regulatory standards within the project scope. Additionally, the QE is responsible for regularly monitoring and updating Quality key process indicators and leading projects aimed at achieving strategic goals and objectives within the context of the assigned projects.

What you will do:

  • Implement inspection plans for components and finished goods within the designated project to ensure product quality and adherence to project requirements.
  • Perform MSA (Measurement Systems Analysis) studies as needed for the implementation of inspections, specifically tailored to the project's parameters and objectives.
  • Provide support for resolving quality issues encountered during the project, addressing them promptly to maintain project timelines and deliverables.
  • Maintain and update standard quality system procedures based on continuous improvement activities, customer feedback, trend analysis of KPIs, and preventive and corrective actions specific to the project.
  • Lead and participate in both internal and external quality system audits related to the project, ensuring compliance, and identifying areas for improvement.
  • Ensure accurate identification of product status, including segregation and identification of nonconforming products at each step of the processes within the project framework.
  • Ensure compliance of processes and products with GMP (Good Manufacturing Practices) and relevant regulatory requirements applicable to the project.
  • Collaborate in internal quality system audits, focusing on project-related processes and procedures.
  • Lead or participate in team efforts to deploy and implement quality and process analysis tools or systems such as PFMEA, control plans, R&R, PDCA, RCA, SPC, Cpk, etc., tailored to the needs of the project.
  • Lead and participate in projects aimed at updating and improving the quality system specifically for the project's objectives and requirements.
  • Participate in the follow-up and approval of product and process changes within the project scope, including IQ, OQ, and PQ activities.
  • Collaborate in general continuous improvement activities related to the project, contributing ideas and efforts to enhance project outcomes.
  • Lead or participate in change control management meetings specific to the project, including document control, master validation plans, and NPI discussions.
  • Ensure the accuracy and timely inspection/calibration of monitoring and measuring devices used within the project.
  • Oversee the inspection of incoming materials for the project, ensuring they meet specified requirements and project standards.
  • Lead the opening and closure of CAPAs specific to the project, ensuring effective and timely responses for each stage and compliance with project-specific CAPA procedures and relevant regulatory requirements.

What you will need:

  • Bachelor's degree in engineering is required
  • ASQ CQE or six sigma GB certification preferred
  • Minimum of 3 years of experience in similar roll in a medical device manufacturing environment required.
  • Considerable experience of quality systems for medical devices.
  • Proficient in MS Office Suite (including Word, Excel and Power Point)
  • Excellent communication skills
  • CFR 820 and applicable regulatory requirements
  • ISO 13485
  • Minitab and Microsoft
  • Conversational & Written English is required
About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.


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