Quality Engineer II

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• 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.
• Specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• 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, inventory control and/or research and development as they apply to product or process quality. 
• Investigate and collaborate in the investigation of atypical events to support product disposition

Qualifications:

• Bachelor Degree in Engineering (Software, Mechanical and Chemical Engineering preferred)
• Two (2) years of relevant experience
• PFMEA
• Experience reviewing and approving validation test plans, reports, and deviations.
• Capable of performing statistical analysis to support validations and product release.
• Experience in medical devices manufacturing.
• Availability for 1st, 2nd and 3rd shift.