Sr. Quality Engineer

• Bachelor’s degree in Engineering ( Software, Mechanical or Chemical) & four (4) years of experience within the Medical Devices or Pharmaceutical industry.
• Bilingual (English and Spanish)
• Skills: Interpersonal/influencing skills.
• Shift: Administrative and according to business needs.
• Experience in:

• Process development and Validation Strategies.
• Design transfer and New product implementation.
• CSV and Equimpent Qualification.
• Develop and approving test plan.
• GMP, and GDP regulations.

• If you seek humanity’s well-being, are oriented to improve collective health while promoting a long-life without pain, then this is a job for you. You can achieve this by applying your interpersonal and bilingual skills, analytical capacity without losing sight of the effectiveness and quality of your results. If you think you got all this (and more!) then bring it on!

• Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests.
• Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, and/or research development.

Flexible & Integrated Technical Services, LLC