Technical Quality Engineering Manager
hace 11 horas
We are a global healthcare leader that creates breakthrough science to improve people's lives. Our vision is to be the most trusted and respected medical device company.
Our commitment to innovation and quality drives us to anticipate changes in medical science and technology, enabling us to deliver solutions that transform patients' lives.
We offer our employees opportunities for growth and learning, as well as a work-life balance that allows them to care for themselves and their families. As part of our team, you will have access to:
- Career development with an international company where you can grow your career and reach your full potential.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies globally by Fortune.
- A company that prioritizes diversity, equity, and inclusion, providing a welcoming environment for all employees.
This role is based in Costa Rica - Alajuela and is part of our Electrophysiology Division. We are advancing the treatment of heart disease through cutting-edge medical technologies, allowing people to restore their health and resume their lives.
As a Technical Quality Engineering Manager, you will work closely with Manufacturing and Engineering teams to ensure compliance with quality system requirements and achieve key performance indicators (KPIs). You will also lead process/product validation activities and collaborate with Research and Development and Regulatory Affairs personnel to obtain support during new product introductions.
Your responsibilities will include owning major quality system investigations, audits, and document change requests. You will develop and maintain quality engineering methodologies, provide leadership and support for commercialized products, manufacturing, and/or system/services support, and work independently with minimal supervision.
You will verify adherence to established quality systems and GMP/ISO standards, complete risk management and risk analysis, revise design verification and validation plans, and provide technical and statistical investigations. You will also conduct advanced statistical data analyses using Minitab, own measuring process capability, process controls, and process validation efforts, and collaborate with microbiology to ensure appropriate environmental monitoring.
Required Qualifications- Bachelor's degree in Engineering.
- 4-6 years of experience in Quality or Engineering positions.
- At least 4 years of experience in Quality or Manufacturing Engineering positions.
- Experience in process improvement tools such as Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma, or Process Control & Monitoring (SPC), Quality Tools.
- Project management experience, participating or leading multi-departmental project teams.
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
- Experience working on FDA, GMP, and ISO 13485 Regulated environments.
- Advanced command of English (required fluent oral and writing communication including technical writing).
- Experience with SAP.
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