Sr Engineer I, Manufacturing at Quasar… · Mexico…

Our Culture

We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

Job Summary

The key responsibilities and /or task of the Senior Manufacturing Engineer I consist of transfer projects (new process and/or products), improving the current manufacturing process (yield, productivity and on time delivery), and support to Operations activities.

Essential Job Duties and Responsibilities

• Follow all Good Manufacturing Practices and SOPs as defined by the Company’s polices ensuring that FDA and Quality Standards are met.
• Responsible for executing transfer projects between other Quasar location or customer locations to Quasar Tecate.
• Leads and coordinates a cross functional team (supply chain, quality, and manufacturing departments) to define clear goals and objectives as well as set the appropriate conditions for each transfer project.
• Prepare and write technical reports and technical data such as validation protocols, qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc.
• Creating/updating work instructions as well as translation of these documents as needed within the Company’s Quality System requirements.
• Key member of the continues improvement team applying; Theory of Constraints, Six Sigma, and Lean Manufacturing methodologies as tools to drive improvements in manufacturing costs, efficiencies, and lead-times.
• Interact with manufacturing lead persons, supervisors and managers as needed to identify, and resolve/ improve manufacturing deficiencies.
• Responsible for managing and execution of EHS (Environmental, Health and Safety) projects and/or regulatory activities within the Tecate facility.
• Establish and utilize project management tools to manage projects with appropriate weekly & monthly report outs and escalation of significant issues when required.
• Responsible for maintaining /modifying and updating the Tecate facility layout.
• Prioritize and manage all new product prototyping.
• Participate and assist as a part of the Internal Audit team as required.
• Performs other duties as assigned by immediate supervisor.
• Acts as a consultant for areas related to his/her expertise.
• Ability to develop an understanding and practice of Quasar values and competencies.
• Values cultural diversity and other differences; fosters an environment where people who are culturally diverse can work together cooperatively and effectively in achieving organizational goals.
• Other duties or projects as assigned.

Education and Experience Requirements

Education:

· Bachelor’s engineering or related technical field.

· Minimum of 5 years experience required in manufacturing industry, preferably in medical device manufacturing

· Previous technical/engineering experience

Preferred Skills and Abilities

• Knowledge of ISO 13485:2003, GMP, FDA, QSR.
• Understanding of common machine shop practices, fixture design and assembly techniques.
• Related experience within international standards (ISO 13485 / 9001), FDA and European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA).
• Well-developed written and verbal communication skills in English and Spanish. Ability to write and comprehend instructions, short correspondence, and memos in both English and Spanish. Interaction with customer is expected in this position.
• Adept at presenting complex topics to customers and management.
• Solid medical device engineering and manufacturing experience.
• Excellent critical thinking skills with the capability to quickly dissect situations and solve problems.
• Able to operate and thrive in a demanding, fast-paced, fluid environment.
• Proficient in navigation and use of the Windows operating system in a networked environment.
• Solid understanding and ability to use Microsoft Office Tools (Outlook, Word, Excel, Project, Visio, PowerPoint, and SharePoint).
• Proficiency in Minitab.
• Working knowledge of 2D and 3D CAD software including Autodesk AutoCAD, Inventor, and Mechanical Desktop.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life-giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

Check out our open positions and bring your passion to life.